Andrew’s Blog

Join us 5-6 December 2017 for MedTech Digital Week, a 2-day series of live educational webcasts and downloadable resources on the latest EU MDR, IVDR and Emerging Market Regulation updates EU MDR Labeling Compliance: Learn the Lessons from UDI EU MDR is being viewed...

Join our Webinar, EU MDR Labeling Compliance: Learn the Lessons from UDI

Join us 5-6 December 2017 for MedTech Digital Week, a 2-day series of live educational webcasts and downloadable resources on the latest EU MDR, IVDR and Emerging Market Regulation updates EU MDR Labeling Compliance: Learn the Lessons from UDI EU MDR is being viewed...

I had the opportunity to attend, chair and present at the IQPC Combination Products Forum in Munich on 24 and 25 October.  Many thanks to Romy Tuin and the team at IQPC for organising the event. I presented on The Implications of the New...

IQPC Combination Products Forum, 24 and 25 October, Munich

I had the opportunity to attend, chair and present at the IQPC Combination Products Forum in Munich on 24 and 25 October.  Many thanks to Romy Tuin and the team at IQPC for organising the event. I presented on The Implications of the New...

A brief overview of the EU MDR and EU IVDR regulations Following approval in March 2017 by the European Council and in April 2017 by the European Parliament, the Medical Devices Regulation (MDR) – Regulation (EU) 2017/745 – and In Vitro Diagnostic Medical Devices...

Is Your Quality Management System Compliant with the New EU MDR and EU IVDR Regulations?

A brief overview of the EU MDR and EU IVDR regulations Following approval in March 2017 by the European Council and in April 2017 by the European Parliament, the Medical Devices Regulation (MDR) – Regulation (EU) 2017/745 – and In Vitro Diagnostic Medical Devices...

The Combination Products Forum, taking place on the 24 – 26 October in Munich, will address challenges surrounding: Navigating your way through contradicting regulations Preparing for the digitalisation trend in combination product use and design Understanding how adjacent legislation will affect the already confusing...

Combination Products Forum, 24 – 26 October, Munich

The Combination Products Forum, taking place on the 24 – 26 October in Munich, will address challenges surrounding: Navigating your way through contradicting regulations Preparing for the digitalisation trend in combination product use and design Understanding how adjacent legislation will affect the already confusing...

The new EU Medical Device and In Vitro Device Regulations are here and companies need to be deciding how they will address them. Approved by the European Parliament in May 2017, these new regulations are the biggest change to the legislative framework for MD...

Have you developed your strategy to address the new EU MD and IVD Regulations?

The new EU Medical Device and In Vitro Device Regulations are here and companies need to be deciding how they will address them. Approved by the European Parliament in May 2017, these new regulations are the biggest change to the legislative framework for MD...

Join us for this 60-minute information packed webinar on Bridging the Gap – How to be EU MDR Labelling Compliance Ready by Using the Lessons Learnt from UDI to discover why EU MDR will change the medical device labelling landscape globally and how to...

Upcoming webinar on EU MDR compliance

Join us for this 60-minute information packed webinar on Bridging the Gap – How to be EU MDR Labelling Compliance Ready by Using the Lessons Learnt from UDI to discover why EU MDR will change the medical device labelling landscape globally and how to...

I had the opportunity to attend, chair and present at the IQPC Pharmaceutical Packaging and Labelling Summit in Zurich on 20 and 21 June. Many thanks to Katherine Gordon and the team at IQPC for organising the event. I presented on The Implications of...

IQPC Pharmaceutical Packaging and Labelling Summit, 20 and 21 June, Zurich

I had the opportunity to attend, chair and present at the IQPC Pharmaceutical Packaging and Labelling Summit in Zurich on 20 and 21 June. Many thanks to Katherine Gordon and the team at IQPC for organising the event. I presented on The Implications of...

Following approval in March by the European Council and in April by the European Parliament, the Medical Devices Regulation (MDR) – Regulation (EU) 2017/745 – and In Vitro Diagnostic Medical Devices Regulation (IVDR) – Regulation (EU) 2017/746 – were published in the Official Journal...

The clock is ticking on the new EU Medical Device and In Vitro Diagnostic Device Regulations

Following approval in March by the European Council and in April by the European Parliament, the Medical Devices Regulation (MDR) – Regulation (EU) 2017/745 – and In Vitro Diagnostic Medical Devices Regulation (IVDR) – Regulation (EU) 2017/746 – were published in the Official Journal...

In this, the last article in the series, we will look at the importance of Culture and then summarise the series. Looking first at tip 10 on culture, you need to ensure you have the right culture, displayed across all teams involved in the...

Right-first-time tip 10: Ensuring you have the right culture to succeed

In this, the last article in the series, we will look at the importance of Culture and then summarise the series. Looking first at tip 10 on culture, you need to ensure you have the right culture, displayed across all teams involved in the...

I believe right-first-time is a key metric and mindset for your artwork process and in this article, I continue my series on top tips to improve it, looking at tip 8, ensuring there is an appropriate and scalable suite of IT tools to support...

Right-first-time tips 8 and 9: Ensuring appropriate IT support, quality time and quality facilities to do quality work

I believe right-first-time is a key metric and mindset for your artwork process and in this article, I continue my series on top tips to improve it, looking at tip 8, ensuring there is an appropriate and scalable suite of IT tools to support...

I believe right-first-time is a key metric and mindset for your artwork process and in this article, I continue my series on top tips to improve it, looking at tip 6, ensuring all the people in the process have the appropriate skills, competencies and...

Right-first-time tips 6 and 7: Ensuring effective training and cross-functional governance

I believe right-first-time is a key metric and mindset for your artwork process and in this article, I continue my series on top tips to improve it, looking at tip 6, ensuring all the people in the process have the appropriate skills, competencies and...

Healthcare Packaging recently published this great article stressing the importance of excellent packaging, labelling and artwork consistency across both physical and digital markets. Did you know that following a diagnosis, 84% of patients turn to an online search to learn more about their treatment...

A useful article in Healthcare Packaging

Healthcare Packaging recently published this great article stressing the importance of excellent packaging, labelling and artwork consistency across both physical and digital markets. Did you know that following a diagnosis, 84% of patients turn to an online search to learn more about their treatment...

I believe right-first-time is a key metric and mindset for your artwork process and in this article, I continue my series on top tips to improve it, looking at tip 4, raising the need for a comprehensive and effective end-to-end process with clear roles...

Right-first-time tips 4 and 5: Ensuring you have an effective end-to-end process and the right quality checks in place

I believe right-first-time is a key metric and mindset for your artwork process and in this article, I continue my series on top tips to improve it, looking at tip 4, raising the need for a comprehensive and effective end-to-end process with clear roles...

Right-first-time, I believe, is a key metric and goal for your artwork process and this week I talk through my third tip, ‘Make sure you have all the information before starting’. Unfortunately many companies start with incomplete information and so here I talk through...

Right-first-time tip 3: Make sure all the information is correct before starting, using an artwork brief

Right-first-time, I believe, is a key metric and goal for your artwork process and this week I talk through my third tip, ‘Make sure you have all the information before starting’. Unfortunately many companies start with incomplete information and so here I talk through...

I believe right-first-time is a key metric and mind set for your artwork process and, in this article, I continue my series on top tips to improve it, raising the need for a detailed understanding of why the errors are happening. Categorise the types...

Right-First-Time tip 2: Categorise and root cause the errors

I believe right-first-time is a key metric and mind set for your artwork process and, in this article, I continue my series on top tips to improve it, raising the need for a detailed understanding of why the errors are happening. Categorise the types...

Right-first-time, I believe, is a key metric and goal for your artwork process and in these next set of articles, I will discuss my suggested top tips for improving this measure.  In this first article, I will talk through the need for measuring, who...

Right-First-Time tip 1: Measure it

Right-first-time, I believe, is a key metric and goal for your artwork process and in these next set of articles, I will discuss my suggested top tips for improving this measure.  In this first article, I will talk through the need for measuring, who...

My latest column has just been posted with Pharma IQ: Do not underestimate the amount of resources required for serialisation To read it, please click here. We hope you find this column interesting.  We are always searching for ways to improve our work and...

My November column has just been posted with Pharma IQ

My latest column has just been posted with Pharma IQ: Do not underestimate the amount of resources required for serialisation To read it, please click here. We hope you find this column interesting.  We are always searching for ways to improve our work and...

I always consider that ‘Right-First-Time’ is the fundamental metric for an artwork service.  This is a simple pass or fail metric – did the artwork pass through the process once or was any change required? This is difficult to achieve on a consistent basis...

Right-First-Time: An Introduction

I always consider that ‘Right-First-Time’ is the fundamental metric for an artwork service.  This is a simple pass or fail metric – did the artwork pass through the process once or was any change required? This is difficult to achieve on a consistent basis...

You have reviewed your artwork service, perhaps in response to a recall incident, made some improvements to the process and tightened up your training but have the changes given you the outcome you desired? The danger is, unless you have some metrics in place,...

Measuring your artwork service

You have reviewed your artwork service, perhaps in response to a recall incident, made some improvements to the process and tightened up your training but have the changes given you the outcome you desired? The danger is, unless you have some metrics in place,...

In my recent set of blogs, I have been talking about the need for and benefits of proof reading in the review and approval of artwork. In this article, I will highlight the need to train the staff involved, talk about the difficulties of...

Proof reading is a GMP activity: this is why training is essential

In my recent set of blogs, I have been talking about the need for and benefits of proof reading in the review and approval of artwork. In this article, I will highlight the need to train the staff involved, talk about the difficulties of...

My recent set of articles has been looking at proofreading. I have talked about the step change it can make in the quality of your process and what is involved.  In this article, I am talking about the difference between what each group reviews...

Proof reading: Who is involved?

My recent set of articles has been looking at proofreading. I have talked about the step change it can make in the quality of your process and what is involved.  In this article, I am talking about the difference between what each group reviews...

How many of you spotted the conscious mistake in the title of my last article on proof reading, ‘Prrof reading: What is involved’? I did it to grab your attention but actually only a few of you saw it and commented. This illustrates how...

Proof reading: The risk with manual checking and what you can do to overcome this

How many of you spotted the conscious mistake in the title of my last article on proof reading, ‘Prrof reading: What is involved’? I did it to grab your attention but actually only a few of you saw it and commented. This illustrates how...

My latest column has just been posted with Pharma IQ: 4 Lessons learnt on the road to serialisation: The supply base is over-stretched To read it, please click here. We hope you find this column interesting.  We are always searching for ways to improve...

My October column has just been posted with Pharma IQ

My latest column has just been posted with Pharma IQ: 4 Lessons learnt on the road to serialisation: The supply base is over-stretched To read it, please click here. We hope you find this column interesting.  We are always searching for ways to improve...

In my last article, I introduced the topic of proof reading and highlighted how including a comprehensive proof reading activity would significantly improve the quality of output from your business’s labelling and artwork operation.  In this article, I am going to talk about where...

Proof reading: what is involved?

In my last article, I introduced the topic of proof reading and highlighted how including a comprehensive proof reading activity would significantly improve the quality of output from your business’s labelling and artwork operation.  In this article, I am going to talk about where...

In the next few articles I want to talk about the important process step – proof reading. I will cover a number of different aspects, including the key steps involved, how these steps are controlled, selection and training of proof readers, what auditors like...

Proof reading: a vital part of your process

In the next few articles I want to talk about the important process step – proof reading. I will cover a number of different aspects, including the key steps involved, how these steps are controlled, selection and training of proof readers, what auditors like...

I recently talked about the relationship with the Packaging Technologists/Engineers and with Regulatory. In this blog I discuss another key group – Planning. I talk through where the groups interact, what behaviours you see when the relationship is not so good and the impact on...

Working with your partners in the business: Planning

I recently talked about the relationship with the Packaging Technologists/Engineers and with Regulatory. In this blog I discuss another key group – Planning. I talk through where the groups interact, what behaviours you see when the relationship is not so good and the impact on...

My latest column has just been posted with Pharma IQ: Lessons Learned on the Road to Serialisation. To read it, please click here. We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any...

My September column has just been posted with Pharma IQ

My latest column has just been posted with Pharma IQ: Lessons Learned on the Road to Serialisation. To read it, please click here. We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any...

I recently talked about the relationship with the Packaging Technologists/Engineers. In this blog I discuss working with the Regulatory function. I talk through the regular interactions, the key information they provide the team and their responsibilities, and the role of senior sponsors. The Regulatory...

Working with your partners in the business: Regulatory

I recently talked about the relationship with the Packaging Technologists/Engineers. In this blog I discuss working with the Regulatory function. I talk through the regular interactions, the key information they provide the team and their responsibilities, and the role of senior sponsors. The Regulatory...

The artwork service team works with many groups in the business, so my next series of blogs will look at the key ones. In this one I will talk about the Packaging Technologists, or Packaging Engineers. I discuss what information they provide the team...

Working with your partners in the business: the Packaging Engineers/Technologists

The artwork service team works with many groups in the business, so my next series of blogs will look at the key ones. In this one I will talk about the Packaging Technologists, or Packaging Engineers. I discuss what information they provide the team...

This week I want to talk about the importance of the artwork brief. In our book ‘Developing and Sustaining Excellent Packaging, Labelling and Artwork Capabilities’ we say it is a key part a world-class process. So here I talk through why I see it...

The importance of the artwork brief

This week I want to talk about the importance of the artwork brief. In our book ‘Developing and Sustaining Excellent Packaging, Labelling and Artwork Capabilities’ we say it is a key part a world-class process. So here I talk through why I see it...

In this week’s blog I am going to look at the use of technology in the artwork process, why it can be particularly helpful, the range of tools available and a short discussion on some of the potential downsides. Technology can be particularly helpful...

Technology- range of tools available

In this week’s blog I am going to look at the use of technology in the artwork process, why it can be particularly helpful, the range of tools available and a short discussion on some of the potential downsides. Technology can be particularly helpful...

In this blog I look at a popular topic often raised by our clients, the question of whether or not to outsource activities involved in their labelling and artwork process. This can indeed be a useful strategy but, as you will see, there are...

Outsourcing – a useful strategy but needs to be carefully considered

In this blog I look at a popular topic often raised by our clients, the question of whether or not to outsource activities involved in their labelling and artwork process. This can indeed be a useful strategy but, as you will see, there are...

My latest column has just been posted with Pharma IQ: Effective cross-functional governance with Serialisation Projects To read it, please click here We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback...

My July column has just been posted with Pharma IQ

My latest column has just been posted with Pharma IQ: Effective cross-functional governance with Serialisation Projects To read it, please click here We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback...

In my blog about supporting processes I stressed the importance of establishing a Governance group. So here I will explain a bit more about why such a group is required, what its purpose is, the roles of the team members and how its focus...

Governance key with your new Labelling and Artwork organisation

In my blog about supporting processes I stressed the importance of establishing a Governance group. So here I will explain a bit more about why such a group is required, what its purpose is, the roles of the team members and how its focus...

I had the opportunity to attend, chair and present at the IQPC Pharmaceutical Packaging and Labelling Summit in Geneva on 22 and 23 June.  Many thanks to Katherine Gordon, Daniella Ndeh and the team at IQPC for organising the event. I presented on the...

IQPC Pharmaceutical Packaging and Labelling Summit, 22 and 23 June, Geneva

I had the opportunity to attend, chair and present at the IQPC Pharmaceutical Packaging and Labelling Summit in Geneva on 22 and 23 June.  Many thanks to Katherine Gordon, Daniella Ndeh and the team at IQPC for organising the event. I presented on the...

The issue of counterfeit drugs continues to increase, with regulators and the pharmaceutical industry taking multiple courses of action to address it. In this article, recently published in World Pharma Today, I discuss the problems presented by counterfeit medications and what is being done...

The Anti-Counterfeit Drug Issue: It’s Real

The issue of counterfeit drugs continues to increase, with regulators and the pharmaceutical industry taking multiple courses of action to address it. In this article, recently published in World Pharma Today, I discuss the problems presented by counterfeit medications and what is being done...

In a previous blog I have talked about the design of the core artwork process and emphasised the importance of having the design in place before looking at the team structure. So here I will talk about putting the team together, the benefits of...

Putting together the Labelling and Artwork organisation

In a previous blog I have talked about the design of the core artwork process and emphasised the importance of having the design in place before looking at the team structure. So here I will talk about putting the team together, the benefits of...

My latest column has just been posted with Pharma IQ: Tips For Creating A Serialisation Strategy To read it, please click here We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback...

My June column has just been posted with Pharma IQ

My latest column has just been posted with Pharma IQ: Tips For Creating A Serialisation Strategy To read it, please click here We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback...

In a previous blog I gave a description of the core artwork process. Having a well-designed artwork process is of course critical to your success, however it is not sufficient enough to provide a complete capability. A number of support processes need to be...

The importance of the supporting processes

In a previous blog I gave a description of the core artwork process. Having a well-designed artwork process is of course critical to your success, however it is not sufficient enough to provide a complete capability. A number of support processes need to be...

In this blog I am going to look at the importance of getting a good fit with other processes in your company that need to operate in conjunction with your artwork process. Getting effective links to these other (interfacing) processes is an important element...

The Artwork process link to the company’s interfacing processes

In this blog I am going to look at the importance of getting a good fit with other processes in your company that need to operate in conjunction with your artwork process. Getting effective links to these other (interfacing) processes is an important element...

In this blog I am going to look at the core artwork process itself. I will be highlighting the key parts of each step and aiming to show what is the difference between a good process and an excellence one. Define your process before...

The Core Artwork process – on the surface it seems so simple to achieve

In this blog I am going to look at the core artwork process itself. I will be highlighting the key parts of each step and aiming to show what is the difference between a good process and an excellence one. Define your process before...

In this blog I am going to continue to talk about the key aspects to think about when you start to develop the Artwork Service capability for your company. In particular I would like to talk about ways of establishing the service culture and...

Developing an Artwork Service – Part 2

In this blog I am going to continue to talk about the key aspects to think about when you start to develop the Artwork Service capability for your company. In particular I would like to talk about ways of establishing the service culture and...

My latest column has just been posted with Pharma IQ: Selecting Implementation Partners for your Serialisation Strategy To read it, please click here: We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback...

My May column has just been posted with Pharma IQ

My latest column has just been posted with Pharma IQ: Selecting Implementation Partners for your Serialisation Strategy To read it, please click here: We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback...

In this blog I am going to focus on the initial steps required when you start to develop an excellent Artwork Service capability for your company. In particular I would like to talk about establishing the dimensions of the provision and the importance of...

Developing an Artwork Service – Part 1

In this blog I am going to focus on the initial steps required when you start to develop an excellent Artwork Service capability for your company. In particular I would like to talk about establishing the dimensions of the provision and the importance of...

In my recent blogs I have focused on the problems and what can go wrong in your company’s artwork provision, but in this blog I would like to talk the key elements I believe you will find when your company has in place an...

Ensuring you have an effective Artwork Capability

In my recent blogs I have focused on the problems and what can go wrong in your company’s artwork provision, but in this blog I would like to talk the key elements I believe you will find when your company has in place an...

In my last post I talked about the importance of having provenance for each artwork element and how gaps here can be a significant underlying cause of artwork error. In this article I discuss what I believe are the two other significant underlying reasons,...

Beware of the concertina effect with other underlying issues

In my last post I talked about the importance of having provenance for each artwork element and how gaps here can be a significant underlying cause of artwork error. In this article I discuss what I believe are the two other significant underlying reasons,...

In my previous blogs I have talked about some of the different types of errors and the impact on your organisation. In this article I talk about what I believe is a significant underlying cause, explaining why mistakes are made, and why the risk...

Why do Artwork Errors Happen?

In my previous blogs I have talked about some of the different types of errors and the impact on your organisation. In this article I talk about what I believe is a significant underlying cause, explaining why mistakes are made, and why the risk...

My latest column has just been posted with Pharma IQ: Tips for your serialisation Strategy – Tips 1 and 2 To read it, please click here: We hope you find this column interesting.  We are always searching for ways to improve our work and would...

My April column has just been posted with Pharma IQ

My latest column has just been posted with Pharma IQ: Tips for your serialisation Strategy – Tips 1 and 2 To read it, please click here: We hope you find this column interesting.  We are always searching for ways to improve our work and would...

My latest column has just been posted with Pharma IQ: Ensuring effective translations- Translation memory To read it, please click here: We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you....

My March column has just been posted with Pharma IQ

My latest column has just been posted with Pharma IQ: Ensuring effective translations- Translation memory To read it, please click here: We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you....

I had the opportunity to attend and chair the first day of the 2nd Anti-Counterfeiting Pharma 2016 Conference in London last week.  Many thanks to Pranita Nangia, Jasneet Gulshan and the team at Recunnect for organising the event. Presentations from Day 1 of the...

2nd Anti-Counterfeiting Pharma 2016 Conference, 9 and 10 March, London

I had the opportunity to attend and chair the first day of the 2nd Anti-Counterfeiting Pharma 2016 Conference in London last week.  Many thanks to Pranita Nangia, Jasneet Gulshan and the team at Recunnect for organising the event. Presentations from Day 1 of the...

We discussed in my previous blog Technical Errors vs Human Errors with labelling and artwork-important you treat them differently,  the main differences in dealing with errors created by humans and technology. Another source of error can be attributed to the lack of robustness or...

Why design and controls are important for your Artwork Program?

We discussed in my previous blog Technical Errors vs Human Errors with labelling and artwork-important you treat them differently,  the main differences in dealing with errors created by humans and technology. Another source of error can be attributed to the lack of robustness or...

In my previous blog post, Working with your external partners to ensure an effective response to an artwork related drug recall, I talked about the significance and impact of labeling and artwork errors in your company. In this blog I discuss the importance of...

Technical errors versus human errors with labelling and artwork- important you treat them differently

In my previous blog post, Working with your external partners to ensure an effective response to an artwork related drug recall, I talked about the significance and impact of labeling and artwork errors in your company. In this blog I discuss the importance of...

Pharmaceutical supply chains are becoming ever more complex, involving an increasing number of external partners.  This week, I want to speak about the external partners that might be involved in an artwork related drug recall and how pharma organisations can work effectively with them...

Working with your external partners to ensure an effective response to an artwork related drug recall

Pharmaceutical supply chains are becoming ever more complex, involving an increasing number of external partners.  This week, I want to speak about the external partners that might be involved in an artwork related drug recall and how pharma organisations can work effectively with them...

Artwork errors are an ongoing risk in a Pharma organization. I already listed the different types of errors you can have in my blog post Excellent Packaging Artwork Capabilities 2 – Consequences of errors, and whilst a number of errors present minimal risk to...

Artwork Errors: Detecting them and minimising their impact

Artwork errors are an ongoing risk in a Pharma organization. I already listed the different types of errors you can have in my blog post Excellent Packaging Artwork Capabilities 2 – Consequences of errors, and whilst a number of errors present minimal risk to...

Pharma and healthcare companies are currently facing many challenges from operating in the global market. Organisations are launching new products and expanding into many new markets resulting in a more complex product portfolio. Added to this, they need to interact with many different stakeholders...

Packaging Artwork and Labelling: a hidden nerve centre of your operation

Pharma and healthcare companies are currently facing many challenges from operating in the global market. Organisations are launching new products and expanding into many new markets resulting in a more complex product portfolio. Added to this, they need to interact with many different stakeholders...

To read it please click here: http://www.pharma-iq.com/clinical/columns/ensuring-effective-translations-%E2%80%93-approving-translation We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

My February column has just been posted with Pharma IQ

To read it please click here: http://www.pharma-iq.com/clinical/columns/ensuring-effective-translations-%E2%80%93-approving-translation We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. After ensuring there is effective cross-functional...

10 Key Learnings you should consider for your Artwork Programme Implementation – Key Learning 10: Make sure your solutions stick

Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. After ensuring there is effective cross-functional...

  Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. After ensuring there is effective...

10 Key Learnings you should consider for your Artwork Programme Implementation. Key Learning 9: Partners

  Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. After ensuring there is effective...

  Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. Following on from the previous...

10 Key Learnings you should consider for your Artwork Programme Implementation – Key Learning 8: Governance

  Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. Following on from the previous...

  Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. After keeping momentum in your...

10 Key Learnings you should consider for your Artwork Programme Implementation – Key Learning 7: The right leadership

  Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. After keeping momentum in your...

To read it please click here: http://www.pharma-iq.com/quality-management/columns/ensuring-effective-translations-%E2%80%93-review-translation We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

My December column has just been posted with Pharma IQ

To read it please click here: http://www.pharma-iq.com/quality-management/columns/ensuring-effective-translations-%E2%80%93-review-translation We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

  Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. After ensuring to implement a...

10 Key Learnings you should consider for your Artwork Programme Implementation – Key Learning 6: Keep momentum

  Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. After ensuring to implement a...

Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. After detailing why it is so...

10 Key Learnings you should consider for your Artwork Programme Implementation – Key Learning 5: Roadmap

Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. After detailing why it is so...

To read it please click here: http://www.pharma-iq.com/market-access/columns/ensuring-effective-translations-prepare-translatio/ We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

My November column has just been posted with Pharma IQ

To read it please click here: http://www.pharma-iq.com/market-access/columns/ensuring-effective-translations-prepare-translatio/ We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. In the last article we talked...

10 Key Learnings you should consider for your Artwork Programme Implementation – Key Learning 4: Communication

Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. In the last article we talked...

Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. In the last article we looked...

10 Key Learnings you should consider for your Artwork Programme Implementation – Key Learning 3: Vision

Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. In the last article we looked...

Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. After compelling the stakeholders across the...

10 Key Learnings you should consider for your Artwork Programme Implementation – Key Learning 2: Sponsorship

Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. After compelling the stakeholders across the...

Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. We start this series of posts...

10 Key Learnings you should consider for your Artwork Programme Implementation – Key Learning 1: Compelling urgency

Like all significant change activity, many artwork improvement programmes commence, but not all are successful. We have learnt many lessons from our involvement in numerous labelling and artwork improvement projects that we believe are key to ensuring success. We start this series of posts...

To read it please click here: http://www.pharma-iq.com/columnarticle.cfm?externalID=20902&columnID=109 We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

My October column has just been posted with Pharma IQ

To read it please click here: http://www.pharma-iq.com/columnarticle.cfm?externalID=20902&columnID=109 We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

  Our experience suggests that serialisation programs often set out from one of two places. On the one hand, there is the first group of programs that are very pragmatic and strive to deliver solutions which are focused on meeting hard legislative requirements and...

Things we wish we had known before starting a serialisation program or project – Tip 13: Do not forget the non-legislative benefits of serialisation

  Our experience suggests that serialisation programs often set out from one of two places. On the one hand, there is the first group of programs that are very pragmatic and strive to deliver solutions which are focused on meeting hard legislative requirements and...

The end-to-end serialisation solution in any organisation is complex and holds a myriad of opportunities for individual solution elements to not work as planned, interfaces to fail and other things to go wrong. In our experience, organisations benefit a great deal from learn­ing first-hand...

Things we wish we had known before starting a serialisation program or project – Tip 12: Get an end-to-end solution working early

The end-to-end serialisation solution in any organisation is complex and holds a myriad of opportunities for individual solution elements to not work as planned, interfaces to fail and other things to go wrong. In our experience, organisations benefit a great deal from learn­ing first-hand...

  In many cases, particularly in track and trace serialisation models, local country teams will have to work with the local supply chain and local suppliers to ensure that robust local el­ements of the overall serialisation solution are implemented. This is in addition to...

Things we wish we had known before starting a serialisation program or project – Tip 11: Involve local country teams and management early

  In many cases, particularly in track and trace serialisation models, local country teams will have to work with the local supply chain and local suppliers to ensure that robust local el­ements of the overall serialisation solution are implemented. This is in addition to...

  Serialisation legislation can be somewhat vague, incomplete and sometimes contradictory, with individual pieces of legislation often evolving over a long period of time. Interpreting the legislation as it evolves and predicting its impacts can present significant challenges. We have found that there are...

Things we wish we had known before starting a serialisation program or project – Tip 10: Ensure you understand the evolution of serialisation legislation and instruct the organisation accordingly

  Serialisation legislation can be somewhat vague, incomplete and sometimes contradictory, with individual pieces of legislation often evolving over a long period of time. Interpreting the legislation as it evolves and predicting its impacts can present significant challenges. We have found that there are...

Serialisation is clearly a complex and evolving topic that touches many parts of an organi­sation. With the challenges facing the leadership that is charged with implementing such capabilities, they need to have a broad range of skills, the drive and motivation to anticipate risks...

Things we wish we had known before starting a serialisation program or project – Tip 9: Put a capable, dynamic and motivated leader on the problem

Serialisation is clearly a complex and evolving topic that touches many parts of an organi­sation. With the challenges facing the leadership that is charged with implementing such capabilities, they need to have a broad range of skills, the drive and motivation to anticipate risks...

  Given the broad reaching impacts of serialisation across an organisation, a great deal of time and effort is required to deliver effective solutions. It is all too easy for projects to focus on aspects such as line solutions and the enterprise IT and...

Things we wish we had known before starting a serialisation program or project – Tip 8: Do not underestimate the amount of resources required to deliver serialisation

  Given the broad reaching impacts of serialisation across an organisation, a great deal of time and effort is required to deliver effective solutions. It is all too easy for projects to focus on aspects such as line solutions and the enterprise IT and...

To read it please click here: http://www.pharma-iq.com/logistics/columns/ensuring-effective-translations-translation-specif/ We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

My August column has just been posted with Pharma IQ

To read it please click here: http://www.pharma-iq.com/logistics/columns/ensuring-effective-translations-translation-specif/ We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

  For larger organisations, where there will be a number of sites, packaging lines and possibly distribution operations to enable for serialisation, developing standard solutions has proved very useful in enabling roll-out in a timely and resource efficient way. Serialisation systems are complex and...

Things we wish we had known before starting a serialisation program or project – Tip 7: Develop and leverage standard solutions where possible

  For larger organisations, where there will be a number of sites, packaging lines and possibly distribution operations to enable for serialisation, developing standard solutions has proved very useful in enabling roll-out in a timely and resource efficient way. Serialisation systems are complex and...

  With the drive to implement initial solutions quickly, it is often tempting to “keep things simple” by selecting and implementing solutions that are only capable of meeting the immediate or limited requirements. Clearly tactical solutions of limited scope and or capability have their...

Things we wish we had known before starting a serialisation program or project – Tip 6: Choose solutions that will be globally capable

  With the drive to implement initial solutions quickly, it is often tempting to “keep things simple” by selecting and implementing solutions that are only capable of meeting the immediate or limited requirements. Clearly tactical solutions of limited scope and or capability have their...

http://www.pharma-iq.com/business-development/columns/translation-providers-choosing-the-cheapest-may-ac/ We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

My July column has just been posted with Pharma IQ. To read it please click here:

http://www.pharma-iq.com/business-development/columns/translation-providers-choosing-the-cheapest-may-ac/ We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

  I attended and spoke at the IQPC Pharmaceutical Packaging and Labelling Summit 2015 in Zurich at the end of June. Many thanks to Ana Vulinovich and the team at IQPC for organising such a great and well attended event. I presented on 10 Key...

IQPC Pharmaceutical Packaging and Labelling Summit 2015, 23-24 June, Zurich

  I attended and spoke at the IQPC Pharmaceutical Packaging and Labelling Summit 2015 in Zurich at the end of June. Many thanks to Ana Vulinovich and the team at IQPC for organising such a great and well attended event. I presented on 10 Key...

To implement effective solutions to address serialisation, it is important to understand the true complexities of the product / supply chain mix. Many day-to-day realities of a modern pharmaceutical supply chain can present significant issues to serialisation implementation activities if not understood early. Situations...

Things we wish we had known before starting a serialisation program or project – Tip 5: Ensure the true complexities of your supply chain are understood early

To implement effective solutions to address serialisation, it is important to understand the true complexities of the product / supply chain mix. Many day-to-day realities of a modern pharmaceutical supply chain can present significant issues to serialisation implementation activities if not understood early. Situations...

  To successfully implement serialisation solutions, pieces of capability need to be implemented across many functions and geographies in an organisation. More often than not, pharmaceutical companies also need to ensure that capabilities are implemented in many third party supply chain partners as well....

Things we wish we had known before starting a serialisation program or project – Tip 4: Ensure a robust cross-organisation impact assessment is carried out and maintained

  To successfully implement serialisation solutions, pieces of capability need to be implemented across many functions and geographies in an organisation. More often than not, pharmaceutical companies also need to ensure that capabilities are implemented in many third party supply chain partners as well....

On 18 June, Leaders in Labeling presented a Lunch & Learn webinar called Strategies for Pursuing Labeling & Artwork Excellence, and kindly invited me to participate. If you missed it, please follow the link below: VIEW THE VIDEO Should you have any questions about...

Leaders in Labeling – June 18 Lunch & Learn Webinar

On 18 June, Leaders in Labeling presented a Lunch & Learn webinar called Strategies for Pursuing Labeling & Artwork Excellence, and kindly invited me to participate. If you missed it, please follow the link below: VIEW THE VIDEO Should you have any questions about...

http://www.pharma-iq.com/columnarticle.cfm?externalID=19423&columnID=109 We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

My June column has just been posted with Pharma IQ. To read it please click here:

http://www.pharma-iq.com/columnarticle.cfm?externalID=19423&columnID=109 We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

  For many years, there has been a great deal of uncertainty in the implementation timing of certain legislation requirements, and legislators have often delayed deadlines. This has had a knock-on effect on the solution providers. Understandably, they have been reluctant to commit to...

Things we wish we had known before starting a serialisation program or project – Tip 3: The supply base is overstretched

  For many years, there has been a great deal of uncertainty in the implementation timing of certain legislation requirements, and legislators have often delayed deadlines. This has had a knock-on effect on the solution providers. Understandably, they have been reluctant to commit to...

  Understandably, in the early days of serialisation in the pharmaceutical industry, the late 2000’s, the technology available and the supply base providing it were, by and large, rela­tively immature. In the intervening years, whilst a significant amount of serialisation legislation has been passed...

Things we wish we had known before starting a serialisation program or project – Tip 2: The technology is still relatively immature

  Understandably, in the early days of serialisation in the pharmaceutical industry, the late 2000’s, the technology available and the supply base providing it were, by and large, rela­tively immature. In the intervening years, whilst a significant amount of serialisation legislation has been passed...

Next June 18th, I will be speaking at the lunch & learn event Strategies for Pursuing Labeling & Artwork Excellence. I would love to have you join our session. Please click on the image below to register for this event. I look forward to...

Leaders in Labeling Lunch & Learn Webinar

Next June 18th, I will be speaking at the lunch & learn event Strategies for Pursuing Labeling & Artwork Excellence. I would love to have you join our session. Please click on the image below to register for this event. I look forward to...

Serialisation is a cross-functional, and in many cases in a typical pharmaceutical company, cross-organisation endeavour, requiring all parties involved to play their part in a coordinat­ed and timely manner. To achieve this in any organization, it is typically necessary to have the appropriate level...

Things we wish we had known before starting a serialisation program or project – Tip 1: Executives need to understand that serialisation will halt sales if implemented poorly

Serialisation is a cross-functional, and in many cases in a typical pharmaceutical company, cross-organisation endeavour, requiring all parties involved to play their part in a coordinat­ed and timely manner. To achieve this in any organization, it is typically necessary to have the appropriate level...

Over the next few weeks, I will be discussing important tips that are intended to help guide you while undertaking your new serialisation program or project. While helping clients implement serialisation programs and projects over the last 10 years, the Be4ward team has recorded...

Things we wish we had known before starting a serialisation program or project – Introduction

Over the next few weeks, I will be discussing important tips that are intended to help guide you while undertaking your new serialisation program or project. While helping clients implement serialisation programs and projects over the last 10 years, the Be4ward team has recorded...

As we complete this series of articles expanding on Ensuring Effective Translations, the next set of tips are to help you plan to have effective document management and how to start building a library of standard phrases. Securely store approved files and build translation...

Ensuring Effective Translations – Translation Memory

As we complete this series of articles expanding on Ensuring Effective Translations, the next set of tips are to help you plan to have effective document management and how to start building a library of standard phrases. Securely store approved files and build translation...

I attended and spoke at the Pharma Packaging Innovation Programme 2015 in Munich this last week.  Many thanks to Mehreen Zafar and the team at World Business Intelligence for organising such an informative event. Presentations I attended were: Holistic Design Approach to Pharma Packaging;...

Pharma Packaging Innovation Programme 2015, 8 May 2015, Munich

I attended and spoke at the Pharma Packaging Innovation Programme 2015 in Munich this last week.  Many thanks to Mehreen Zafar and the team at World Business Intelligence for organising such an informative event. Presentations I attended were: Holistic Design Approach to Pharma Packaging;...

http://www.pharma-iq.com/regulatory-legal/columns/ensuring-effective-translations-initiate-your-proj/ We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

My May column has just been posted with Pharma IQ. To read it please click here:

http://www.pharma-iq.com/regulatory-legal/columns/ensuring-effective-translations-initiate-your-proj/ We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

As we approach the end of this series of articles expanding on Ensuring Effective Translations, the next set of tips are to help you make sure that the final formal approval of the translation goes as planned. Once the translation reviews have been completed...

Ensuring Effective Translations – Approving the translation

As we approach the end of this series of articles expanding on Ensuring Effective Translations, the next set of tips are to help you make sure that the final formal approval of the translation goes as planned. Once the translation reviews have been completed...

Continuing in this series of articles expanding on Ensuring Effective Translations, the next set of tips are to help you make sure that the correct quality assurance steps are undertaken to make sure the translation is correct. Determine up front who will conduct the...

Ensuring Effective Translations – Review Translation

Continuing in this series of articles expanding on Ensuring Effective Translations, the next set of tips are to help you make sure that the correct quality assurance steps are undertaken to make sure the translation is correct. Determine up front who will conduct the...

Continuing in this series of articles expanding on Ensuring Effective Translations, the next set of tips are to help you make sure that the information you are giving to your service provider is well prepared. Take a systematic approach to preparing the translation Having...

Ensuring Effective Translations – Prepare Translation

Continuing in this series of articles expanding on Ensuring Effective Translations, the next set of tips are to help you make sure that the information you are giving to your service provider is well prepared. Take a systematic approach to preparing the translation Having...

http://www.pharma-iq.com/regulatory-legal/columns/ensuring-effective-translations-define-your-approa/ We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com

My April column has just been posted with Pharma IQ. To read it please click here:

http://www.pharma-iq.com/regulatory-legal/columns/ensuring-effective-translations-define-your-approa/ We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com

Continuing in this series of articles expanding on Ensuring Effective Translations, the next set of tips are to help you make sure that the information you are giving to your service provider is well organised and clear. Ensure there is a comprehensive instruction to...

Ensuring Effective Translations – Brief Translation Provider

Continuing in this series of articles expanding on Ensuring Effective Translations, the next set of tips are to help you make sure that the information you are giving to your service provider is well organised and clear. Ensure there is a comprehensive instruction to...

Continuing this short series on the presentations made during the Anti-Counterfeiting Pharma 2015 conference in London that I attended and chaired in early March, below are the remainder of the highlights that I thought may interest you. Again, many thanks to Mukesh Shant and...

Anti-Counterfeiting Pharma 2015, 11-12 March 2015, London – Part 2

Continuing this short series on the presentations made during the Anti-Counterfeiting Pharma 2015 conference in London that I attended and chaired in early March, below are the remainder of the highlights that I thought may interest you. Again, many thanks to Mukesh Shant and...

I attended and chaired the Anti-Counterfeiting Pharma 2015 conference in London this past week. Many thanks to Mukesh Shant and the team at Recunnect for organising such a great and well attended event. Over the next two weeks, I will provide you with a...

Anti-Counterfeiting Pharma 2015, 11-12 March 2015, London – Part 1

I attended and chaired the Anti-Counterfeiting Pharma 2015 conference in London this past week. Many thanks to Mukesh Shant and the team at Recunnect for organising such a great and well attended event. Over the next two weeks, I will provide you with a...

http://www.pharma-iq.com/regulatory-legal/columns/ensuring-effective-translations-introduction/ We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

My March column has just been posted with Pharma IQ. To read it please click here:

http://www.pharma-iq.com/regulatory-legal/columns/ensuring-effective-translations-introduction/ We hope you find this column interesting.  We are always searching for ways to improve our work and would welcome any feedback from you. Please do not hesitate to contact us at enquiries@be4ward.com.

As we hit the halfway mark in this series of articles covering the basics on Ensuring Effective Translations, the next set of tips guide you through establishing a set of standards for working with your translation provider. Translation standards Two notable standards for translations...

Ensuring Effective Translations – Translation Specifications

As we hit the halfway mark in this series of articles covering the basics on Ensuring Effective Translations, the next set of tips guide you through establishing a set of standards for working with your translation provider. Translation standards Two notable standards for translations...

As we continue in this series of articles covering the basics on Ensuring Effective Translations, the next set of tips are to help ensure that the translation provider you propose to use is fit for purpose. Choose professional language translation services carefully For most...

Ensuring Effective Translations – Choose Translation Provider

As we continue in this series of articles covering the basics on Ensuring Effective Translations, the next set of tips are to help ensure that the translation provider you propose to use is fit for purpose. Choose professional language translation services carefully For most...

I attended and spoke at the 5th Annual Pharmaceutical Innovation & Manufacturing Strategies Leaders’ Summit 2015 in London this past week. Many thanks to Nick Williams and the team at GBX Summits for organising such a great and well attended event. Presentations I attended...

5th Annual Pharmaceutical Innovation & Manufacturing Strategies Leaders’ Summit, 10-11 February 2015, London

I attended and spoke at the 5th Annual Pharmaceutical Innovation & Manufacturing Strategies Leaders’ Summit 2015 in London this past week. Many thanks to Nick Williams and the team at GBX Summits for organising such a great and well attended event. Presentations I attended...

My February column has just been posted with Pharma IQ. To read it please click here: http://www.pharma-iq.com/logistics/columns/auditing-artwork-processes-and-services-tips-17-to/

February Column with Pharma IQ

My February column has just been posted with Pharma IQ. To read it please click here: http://www.pharma-iq.com/logistics/columns/auditing-artwork-processes-and-services-tips-17-to/

Continuing in this series of articles expanding on Ensuring Effective Translations, the next set of tips are to help you make sure that the text you are supplying for translation is prepared in way that allows for a high quality translation.  Prepare before you...

Ensuring Effective Translations – Prepare text for translation

Continuing in this series of articles expanding on Ensuring Effective Translations, the next set of tips are to help you make sure that the text you are supplying for translation is prepared in way that allows for a high quality translation.  Prepare before you...

As we continue in this series of articles expanding on Ensuring Effective Translations to help you establish your translation capability, the next set of tips are based around step 2 – Initiate your project. Define your project clearly and in detail Before you start...

Ensuring Effective Translations – Initiate your project

As we continue in this series of articles expanding on Ensuring Effective Translations to help you establish your translation capability, the next set of tips are based around step 2 – Initiate your project. Define your project clearly and in detail Before you start...

As outlined in my previous post on this subject, in this series of articles we are looking at a set of tips based around a ten step process to help you establish your translation capability.  The first set of tips are based around step...

Ensuring Effective Translations – Define your approach for translation

As outlined in my previous post on this subject, in this series of articles we are looking at a set of tips based around a ten step process to help you establish your translation capability.  The first set of tips are based around step...

As globalisation increases and companies reach customers in many more markets around the world, the need for accurate and comprehensive translations increases. Translation activity is an often forgotten back-room process.  It is rarely considered core to a company’s operations, but failure in the process...

Ensuring Effective Translations – Introduction

As globalisation increases and companies reach customers in many more markets around the world, the need for accurate and comprehensive translations increases. Translation activity is an often forgotten back-room process.  It is rarely considered core to a company’s operations, but failure in the process...

My January column has just been posted with Pharma IQ. To read it please click here: http://www.pharma-iq.com/columnarticle.cfm?externalID=18551&columnID=109

January Column with Pharma IQ

My January column has just been posted with Pharma IQ. To read it please click here: http://www.pharma-iq.com/columnarticle.cfm?externalID=18551&columnID=109

My December column has just been posted with Pharma IQ. To read it please click here: http://pharma-iq.com/logistics/columns/auditing-artwork-processes-and-services-tips-9-to/

December Column with Pharma IQ

My December column has just been posted with Pharma IQ. To read it please click here: http://pharma-iq.com/logistics/columns/auditing-artwork-processes-and-services-tips-9-to/

As a place to start, we would recommend a small focussed piece of work which has the following objectives: Understand the issue as it relates to your business. Understand the likely impact across your organisation. Identify, educate and mobilise an effective cross-functional governance team....

10 tips for developing a serialisation strategy – Tip 10: Understand where to start

As a place to start, we would recommend a small focussed piece of work which has the following objectives: Understand the issue as it relates to your business. Understand the likely impact across your organisation. Identify, educate and mobilise an effective cross-functional governance team....

Given the cross-functional and cross-organisational nature of the serialisation capabilities, establishing the right inclusive leadership and governance is key to the long-term success of the activity. All stakeholder groups involved in the delivery of the serialisation capability need to contribute effectively or the whole...

10 tips for developing a serialisation strategy – Tip 9: Implement effective cross-functional governance

Given the cross-functional and cross-organisational nature of the serialisation capabilities, establishing the right inclusive leadership and governance is key to the long-term success of the activity. All stakeholder groups involved in the delivery of the serialisation capability need to contribute effectively or the whole...

The next tip addresses developing and agreeing the key principles required to govern the lifecycle of the serialisation capability. These principles should provide guidance for teams on what is permissible or not and would be approved and managed via the governance team. Examples of...

10 tips for developing a serialisation strategy – Tip 8: Define and agree some governing principles

The next tip addresses developing and agreeing the key principles required to govern the lifecycle of the serialisation capability. These principles should provide guidance for teams on what is permissible or not and would be approved and managed via the governance team. Examples of...

My November column has just been posted with Pharma IQ. To read it please click here: http://www.pharma-iq.com/columnarticle.cfm?externalID=18342&columnID=109

November Column with Pharma IQ

My November column has just been posted with Pharma IQ. To read it please click here: http://www.pharma-iq.com/columnarticle.cfm?externalID=18342&columnID=109

Serialisation legislation and responses are emerging across the globe from multiple differ­ent parties. Whilst often based of standard building blocks, the detail of the requirements shows significant variation. Whilst this is frustrating and a global set of common standards and solutions may be more...

10 tips for developing a serialisation strategy – Tip 7: The need for flexibility

Serialisation legislation and responses are emerging across the globe from multiple differ­ent parties. Whilst often based of standard building blocks, the detail of the requirements shows significant variation. Whilst this is frustrating and a global set of common standards and solutions may be more...

Firstly there is a need to consider what is being standardised. There are some elements of the strategy and resultant solutions that need to defined, built and operated at a global level so that all supply chain nodes can be supported. Other capabilities may...

10 tips for developing a serialisation strategy – Tip 6: Understand global versus local. The question of global versus local needs to be considered on several different dimensions.

Firstly there is a need to consider what is being standardised. There are some elements of the strategy and resultant solutions that need to defined, built and operated at a global level so that all supply chain nodes can be supported. Other capabilities may...

My October column has just been posted with Pharma IQ. To read it please click here: http://www.pharma-iq.com/manufacturing/columns/auditing-artwork-processes-and-services-tips-1-to/

October Column with Pharma IQ

My October column has just been posted with Pharma IQ. To read it please click here: http://www.pharma-iq.com/manufacturing/columns/auditing-artwork-processes-and-services-tips-1-to/

The specific challenge during the design, build, test and implementation phases of solution projects is to resource them with sufficient serialisation subject matter skills and knowledge to avoid common pitfalls, reduce wasted effort and the risks of delay and solution failure. Organisations need to...

10 tips for developing a serialisation strategy – Tip 5: Resource implementation projects with sufficient serialisation specific knowledge to minimise the risk of wasted resources, delays and implementation failure

The specific challenge during the design, build, test and implementation phases of solution projects is to resource them with sufficient serialisation subject matter skills and knowledge to avoid common pitfalls, reduce wasted effort and the risks of delay and solution failure. Organisations need to...

Serialisation legislation is relatively new to the pharmaceutical industry and therefore the solutions available from the supply base are correspondingly immature and in many cases evolving. Supplier selection will often be the start of a very long relationship, as solutions that are initially implemented...

10 tips for developing a serialisation strategy – Tip 4: Understand the immature and evolving solution supply base and select appropriate implementation partners

Serialisation legislation is relatively new to the pharmaceutical industry and therefore the solutions available from the supply base are correspondingly immature and in many cases evolving. Supplier selection will often be the start of a very long relationship, as solutions that are initially implemented...

There are often a number of supply chain configurations and technical options that can be brought to bear with particular serialisation legislative requirements. Short term tactical options have to be weighed against longer term strategic solutions. Some of the challenges that need to be...

10 tips for developing a serialisation strategy – Tip 3: Define solutions and implementation plans which strike the optimal balance between ensuring product supply and the caution that is prudent with this evolving legislation

There are often a number of supply chain configurations and technical options that can be brought to bear with particular serialisation legislative requirements. Short term tactical options have to be weighed against longer term strategic solutions. Some of the challenges that need to be...

Serialisation presents a potentially broad impact on a typical organisation. It is important to engage all of the potentially impacted parties early in the impact assessment phase to ensure that comprehensive solutions can be defined. A further challenge is that multiple pieces of evolving...

10 tips for developing a serialisation strategy – Tip 2: Understand the full impact of these multiple pieces of legislation on the company and product supply chain

Serialisation presents a potentially broad impact on a typical organisation. It is important to engage all of the potentially impacted parties early in the impact assessment phase to ensure that comprehensive solutions can be defined. A further challenge is that multiple pieces of evolving...

Serialisation legislation, particularly in its early iterations, tends to be somewhat vague, in­complete and sometimes contradictory. Interpreting the legislation and predicting its im­pacts can present significant challenges, requiring specific serialisation knowledge as well as new legislative relationships with local legislators. This is further compounded...

10 tips for developing a serialisation strategy – Tip 1: Identify and interpret the emerging and evolving legislation

Serialisation legislation, particularly in its early iterations, tends to be somewhat vague, in­complete and sometimes contradictory. Interpreting the legislation and predicting its im­pacts can present significant challenges, requiring specific serialisation knowledge as well as new legislative relationships with local legislators. This is further compounded...

My September column has just been posted with Pharma IQ.  To read it please click here: http://www.pharma-iq.com/columnarticle.cfm?externalID=17989&columnID=109

September Column with Pharma IQ

My September column has just been posted with Pharma IQ.  To read it please click here: http://www.pharma-iq.com/columnarticle.cfm?externalID=17989&columnID=109

In this series of articles I am going to discuss the topic developing a Serialisation Strategy and outline a series of tips on approaches you can take to go about this. Serialisation legislation will require new capabilities to be implemented across many differ­ent functions...

10 tips for developing a Serialisation Strategy – Introduction

In this series of articles I am going to discuss the topic developing a Serialisation Strategy and outline a series of tips on approaches you can take to go about this. Serialisation legislation will require new capabilities to be implemented across many differ­ent functions...

Proofreading is a critical quality control step in the process of ensuring that the artwork that appears on finished product is correct. Mistakes in this artwork can, and have, put patient safety at risk. Therefore, we would recommend that any tools that are relied...

Causes of Proofreading Errors 15 – Electronic tools not identifying errors due to a lack of validation

Proofreading is a critical quality control step in the process of ensuring that the artwork that appears on finished product is correct. Mistakes in this artwork can, and have, put patient safety at risk. Therefore, we would recommend that any tools that are relied...

My July column has just been posted with Pharma IQ.  To read it please click here:   http://www.pharma-iq.com/informatics/columns/managing-serialisation-impacts-of-serialisation/  

August Column with Pharma IQ

My July column has just been posted with Pharma IQ.  To read it please click here:   http://www.pharma-iq.com/informatics/columns/managing-serialisation-impacts-of-serialisation/  

Modern electronic proofreading tools provide an excellent way of minimising the risk of artwork errors going undetected. Table 14.1 lists the typical types of tools used during proofreading activity. Table 14.1 Typical Proofreading Tools Tool Type Typical Uses in Proofreading Text Comparison Comparing source...

Causes of Proofreading Errors 14 – Relying on electronic proofreading tools to do everything

Modern electronic proofreading tools provide an excellent way of minimising the risk of artwork errors going undetected. Table 14.1 lists the typical types of tools used during proofreading activity. Table 14.1 Typical Proofreading Tools Tool Type Typical Uses in Proofreading Text Comparison Comparing source...

One very simple reason for inadequate proofreading being performed is that the appropriate tools are not available. At it’s simplest level, we have come across situations where there was no way for the proof reader to print out documents at full size and perform...

Causes of Proofreading Errors 13 – Not proofreading all elements because of a lack of tools

One very simple reason for inadequate proofreading being performed is that the appropriate tools are not available. At it’s simplest level, we have come across situations where there was no way for the proof reader to print out documents at full size and perform...

As anyone involved in Quality will tell you that not providing adequate quality time to perform tasks is a sure way to introduce errors and non-compliance. Proofreading is no exception to this rule and seems to suffer particularly badly due to the nature of...

Causes of Proofreading Errors 12 – Not ensuring that people have quality time to do their work

As anyone involved in Quality will tell you that not providing adequate quality time to perform tasks is a sure way to introduce errors and non-compliance. Proofreading is no exception to this rule and seems to suffer particularly badly due to the nature of...

My July column has just been posted with Pharma IQ.  To read it please click here: http://www.pharma-iq.com/manufacturing/columns/managing-serialisation-standards-and-opportunities/  

July Column with Pharma IQ

My July column has just been posted with Pharma IQ.  To read it please click here: http://www.pharma-iq.com/manufacturing/columns/managing-serialisation-standards-and-opportunities/  

Proofreading requires concentration on often large documents for extended periods of time. A small desk and laptop in a busy, noisy open plan office is hardly conducive to performing this task well. In all cases we would recommend that the office environment in which...

Causes of Proofreading Errors 11 – Not ensuring people have the right environment to work in

Proofreading requires concentration on often large documents for extended periods of time. A small desk and laptop in a busy, noisy open plan office is hardly conducive to performing this task well. In all cases we would recommend that the office environment in which...

If we were to list some of the attributes of someone ideally suited to the proofreading task it might look something like this: •   High process compliance focus. •   Strong attention to detail. •   High self discipline. •   A completer...

Causes of Proofreading Errors 10 – Not ensuring that people have the right skills and temperament

If we were to list some of the attributes of someone ideally suited to the proofreading task it might look something like this: •   High process compliance focus. •   Strong attention to detail. •   High self discipline. •   A completer...

Proofreading requires a great deal of concentration and can often take a considerable period of time. For example, it is not uncommon for a manual proofread of a long multi-language leaflet to take a day to complete. Furthermore, because of the nature of the...

Causes of Proofreading Errors 9 – Not using checklist to ensure everything is being done

Proofreading requires a great deal of concentration and can often take a considerable period of time. For example, it is not uncommon for a manual proofread of a long multi-language leaflet to take a day to complete. Furthermore, because of the nature of the...

Artworks often exist in a number of different forms, each one having subtle differences. Take for example the situation where a single artwork is used to create one or more print ready files for one or more printing machines. In this case the artwork,...

Causes of Proof Reading Errors 8 – Not proofreading all instances of an artwork

Artworks often exist in a number of different forms, each one having subtle differences. Take for example the situation where a single artwork is used to create one or more print ready files for one or more printing machines. In this case the artwork,...

In the last article we talked about unique identification and getting the unique identification onto the product or shipping unit. In this article we will discuss publishing the related serialisation information and two of the common serialisation models, Authentication and Track and Trace. Product...

Managing Serialisation – Authentication and Track and Trace

In the last article we talked about unique identification and getting the unique identification onto the product or shipping unit. In this article we will discuss publishing the related serialisation information and two of the common serialisation models, Authentication and Track and Trace. Product...

IQPC Pharmaceutical Packaging and Labelling conference in Basel I spent a few days last week at the IQPC pharmaceutical Packaging and labelling conference in Basel. A big thank you to Anastasia, Michael, Gerald and the team at IQPC for organising another excellent conference.  ...

IQPC Pharmaceutical Packaging and Labelling conference in Basel

IQPC Pharmaceutical Packaging and Labelling conference in Basel I spent a few days last week at the IQPC pharmaceutical Packaging and labelling conference in Basel. A big thank you to Anastasia, Michael, Gerald and the team at IQPC for organising another excellent conference.  ...

The act of proofreading inevitably means verifying information from source documents or systems with the information contained in the finished document. Many artwork errors have occurred because individuals have used the wrong source data or documents. The first example of this would be the...

Causes of Proofreading Errors 7 – Not ensuring source data and documents are correct

The act of proofreading inevitably means verifying information from source documents or systems with the information contained in the finished document. Many artwork errors have occurred because individuals have used the wrong source data or documents. The first example of this would be the...

The human brain is excellent at filling in gaps in information and correcting mistakes in information so that it can see meaning very quickly. As an example, try to read the following: Cna yuo raed tihs? 55 plepoe out of 100 can. i cdnuolt...

Causes of Proofreading Errors 6 – Not using techniques that “disable” the human mind’s ability to auto-correct

The human brain is excellent at filling in gaps in information and correcting mistakes in information so that it can see meaning very quickly. As an example, try to read the following: Cna yuo raed tihs? 55 plepoe out of 100 can. i cdnuolt...

Packaging artwork often contains multiple instances of the same information. For example, the product name and strength will often appear on multiple faces of a carton, or will be stated many times within a leaflet. Many recalls have occurred because one or more instances...

Causes of Proofreading Errors 5 – Not Checking Multiple Instances of the Same Information

Packaging artwork often contains multiple instances of the same information. For example, the product name and strength will often appear on multiple faces of a carton, or will be stated many times within a leaflet. Many recalls have occurred because one or more instances...

My latest column has just been posted with Pharma IQ.  To read it, please click here http://www.pharma-iq.com/manufacturing/columns/managing-serialisation-the-situation-in-2014/

May Column with Pharma IQ

My latest column has just been posted with Pharma IQ.  To read it, please click here http://www.pharma-iq.com/manufacturing/columns/managing-serialisation-the-situation-in-2014/

The nature of the artwork process means that there are many occasions where only a small part of the artwork needs to be updated to affect the desired change. This may be because the overall change in question is only minor, or it may...

Causes of Proofreading Errors 4 – Not checking for inadvertent Changes

The nature of the artwork process means that there are many occasions where only a small part of the artwork needs to be updated to affect the desired change. This may be because the overall change in question is only minor, or it may...

Packaging artwork contains information and elements such as barcodes and Braille from many different sources. In many cases, this information becomes available, or final, at different stages in the process of preparing and approving the artwork. We have encountered situations where artwork has been...

Causes of Proofreading Errors 3 – Not proofreading the complete document

Packaging artwork contains information and elements such as barcodes and Braille from many different sources. In many cases, this information becomes available, or final, at different stages in the process of preparing and approving the artwork. We have encountered situations where artwork has been...

My latest column has just been posted with Pharma IQ.  To read it, please click here http://www.pharma-iq.com/business-development/columns/tips-for-dealing-with-packaging-complexity-part/

April Column with Pharma IQ

My latest column has just been posted with Pharma IQ.  To read it, please click here http://www.pharma-iq.com/business-development/columns/tips-for-dealing-with-packaging-complexity-part/

As we discussed in the introduction, proofreading in the context of this discussion consists of a number of distinctly different types of checks. Furthermore, artwork typically contains information from many different sources. We have observed many instances where individuals are asked to check a...

Causes of Proofreading Errors 2 – Not being clear who should be checking what

As we discussed in the introduction, proofreading in the context of this discussion consists of a number of distinctly different types of checks. Furthermore, artwork typically contains information from many different sources. We have observed many instances where individuals are asked to check a...

Just like any other task, anyone responsible for performing proofreading activities needs to understand exactly how they are supposed to perform each task in an optimal way. Work instructions and procedures should be designed to explain exactly what needs to be done and the...

Causes of Proof Reading Errors 1 – Not having a comprehensive set of work instructions, training and competency assessment

Just like any other task, anyone responsible for performing proofreading activities needs to understand exactly how they are supposed to perform each task in an optimal way. Work instructions and procedures should be designed to explain exactly what needs to be done and the...

It is highly likely that one or more parts of your organisation are already working on this issue, perhaps in a coordinated way, perhaps not. Initially, we would recommend continuing this work until the appropriate course of action has been decided. We would recommend...

Managing Serialisation 9 – Where to start

It is highly likely that one or more parts of your organisation are already working on this issue, perhaps in a coordinated way, perhaps not. Initially, we would recommend continuing this work until the appropriate course of action has been decided. We would recommend...

Companies are faced with several specific issues when managing serialisation related legislation, these include: Identifying and interpreting the emerging and evolving legislation. Serialisation legislation, particularly in its early iterations, tends to be somewhat vague, incomplete and sometimes contradictory. Interpreting the legislation and predicting it’s...

Managing Serialisation 8 – What needs to be done

Companies are faced with several specific issues when managing serialisation related legislation, these include: Identifying and interpreting the emerging and evolving legislation. Serialisation legislation, particularly in its early iterations, tends to be somewhat vague, incomplete and sometimes contradictory. Interpreting the legislation and predicting it’s...

Be4ward will be presenting at the ‘Making Pharmaceuticals’ Event on 29 and 30 April 2014.  The event will be held at the NMM Exhibition Centre at the National Motorcycle Museum, Birmingham, UK. ·       Andrew Love will be presenting on ‘Managing Packaging Complexity in an Ever Increasing...

Be4ward presenting at Making Pharmaceuticals

Be4ward will be presenting at the ‘Making Pharmaceuticals’ Event on 29 and 30 April 2014.  The event will be held at the NMM Exhibition Centre at the National Motorcycle Museum, Birmingham, UK. ·       Andrew Love will be presenting on ‘Managing Packaging Complexity in an Ever Increasing...

My latest column has just been posted with Pharma IQ.  To read it, please click here: http://www.pharma-iq.com/manufacturing/columns/tips-for-dealing-with-packaging-complexity-part-/

March Column with Pharma IQ

My latest column has just been posted with Pharma IQ.  To read it, please click here: http://www.pharma-iq.com/manufacturing/columns/tips-for-dealing-with-packaging-complexity-part-/

Serialisation legislation will require new capabilities to be implemented across many different functions of a typical company. The more obvious impacts include: Packaging operations, where serialisation will have to be applied to product packaging at one or more levels. In the more complex serialisation...

Managing Serialisation 7 – Impacts of Serialisation

Serialisation legislation will require new capabilities to be implemented across many different functions of a typical company. The more obvious impacts include: Packaging operations, where serialisation will have to be applied to product packaging at one or more levels. In the more complex serialisation...

Whilst the primary objective of many organisations will be to meet the requirements of the emerging serialisation legislation, serialisation presents other opportunities. I have listed a few below, but please feel free to add others if you have them. Improved Compliance and Persistence Linking...

Managing Serialisation 6 – Opportunities beyond legislative compliance

Whilst the primary objective of many organisations will be to meet the requirements of the emerging serialisation legislation, serialisation presents other opportunities. I have listed a few below, but please feel free to add others if you have them. Improved Compliance and Persistence Linking...

In the last article we talked about arguably the most complex of serialisation models, Track & Trace. In this article we will discuss some other aspects and the important topic of standards. Reverse and Abnormal Process Flows It should be noted that reverse product...

Managing Serialisation 5 – The Basics and Standards

In the last article we talked about arguably the most complex of serialisation models, Track & Trace. In this article we will discuss some other aspects and the important topic of standards. Reverse and Abnormal Process Flows It should be noted that reverse product...

In the last article we talked about publishing serialisation information and the simplest of serialisation models, Authentication. In this article we will discuss arguably the most complex serialisation model, Track and Trace. Track & Trace Track and trace legislative models attempt to further improve...

Managing Serialisation 4 – The Basics and Track & Trace

In the last article we talked about publishing serialisation information and the simplest of serialisation models, Authentication. In this article we will discuss arguably the most complex serialisation model, Track and Trace. Track & Trace Track and trace legislative models attempt to further improve...

My latest column has just been posted with Pharma IQ.  To read it, please click here: http://www.pharma-iq.com/regulatory-legal/columns/tips-for-dealing-with-packaging-complexity-part-i/

February Column with Pharma IQ

My latest column has just been posted with Pharma IQ.  To read it, please click here: http://www.pharma-iq.com/regulatory-legal/columns/tips-for-dealing-with-packaging-complexity-part-i/

In the last article we talked about unique identification and getting the unique identification onto the product or shipping unit. In this article we will discuss publishing the related serialisation information and one of the common serialisation models, Authentication. Product Information Notification Typically, once...

Managing Serialisation 3 – The Basics and Authentication

In the last article we talked about unique identification and getting the unique identification onto the product or shipping unit. In this article we will discuss publishing the related serialisation information and one of the common serialisation models, Authentication. Product Information Notification Typically, once...

We will break serialisation legislative requirements down into four elements to help explain them: ● Unique Identification ● Product Information Notification ● Authentication ● Track & Trace In this article we will discuss the first of these, unique identification. Unique Identification All serialisation legislation...

Managing Serialisation 2 – The Basics and Unique Identification

We will break serialisation legislative requirements down into four elements to help explain them: ● Unique Identification ● Product Information Notification ● Authentication ● Track & Trace In this article we will discuss the first of these, unique identification. Unique Identification All serialisation legislation...

Pharmaceutical product serialisation legislation is being developed and approved across the World to ensure patient safety and prevent fraud. Achieving this across the supply chain is a major and very costly undertaking. Failure to comply with these legislative requirements will mean that pharmaceutical companies...

Managing Serialisation 1 – The situation in 2014

Pharmaceutical product serialisation legislation is being developed and approved across the World to ensure patient safety and prevent fraud. Achieving this across the supply chain is a major and very costly undertaking. Failure to comply with these legislative requirements will mean that pharmaceutical companies...

My latest column has just been posted with Pharma IQ.  To read it, please click here http://www.pharma-iq.com/market-access/columns/tips-for-dealing-with-packaging-complexity-part-ii/

January Column with Pharma IQ

My latest column has just been posted with Pharma IQ.  To read it, please click here http://www.pharma-iq.com/market-access/columns/tips-for-dealing-with-packaging-complexity-part-ii/

Are you already planning for how you will introduce required future legislation? Discussion No matter how well you manage your current portfolio, there will always be new challenges to drive further complexity.  New aspects of legislation will arise, requiring new solutions to provide.  At...

Packaging Complexity Management Tip 20: Plan for future legislation

Are you already planning for how you will introduce required future legislation? Discussion No matter how well you manage your current portfolio, there will always be new challenges to drive further complexity.  New aspects of legislation will arise, requiring new solutions to provide.  At...

My latest column has just been posted with Pharma IQ.  To read it, please click here http://www.pharma-iq.com/business-development/columns/4-tips-for-dealing-with-packaging-complexity/

December Column with Pharma IQ

My latest column has just been posted with Pharma IQ.  To read it, please click here http://www.pharma-iq.com/business-development/columns/4-tips-for-dealing-with-packaging-complexity/

Have you considered outsourcing the things you are not best equipped to do? Discussion Another facet of the design of your supply chain is the ‘make or buy’ decision. It may be tempting to try to keep all of the volume in house, but...

Packaging Complexity Management Tip 19: Outsourcing

Have you considered outsourcing the things you are not best equipped to do? Discussion Another facet of the design of your supply chain is the ‘make or buy’ decision. It may be tempting to try to keep all of the volume in house, but...

Have you optimised your supply chain to provide required levels of variation and customisation? Discussion In coping with complexity, it is necessary to think not just of what must be done and how, but also where.  To minimise obsolescence the goal should be to...

Packaging Complexity Management Tip 18: Supply Chain design and Hubs

Have you optimised your supply chain to provide required levels of variation and customisation? Discussion In coping with complexity, it is necessary to think not just of what must be done and how, but also where.  To minimise obsolescence the goal should be to...

Have you maximised your opportunities for fast changeover? Discussion Line change-overs are non-productive time and in a world of increasing complexity and product variants, the amount of changeovers increases and so lines can spend significant amounts of time not producing product.  This reduces capacity...

Packaging Complexity Management Tip 17: Reduce line change-over time

Have you maximised your opportunities for fast changeover? Discussion Line change-overs are non-productive time and in a world of increasing complexity and product variants, the amount of changeovers increases and so lines can spend significant amounts of time not producing product.  This reduces capacity...

Have you got the right type of packaging equipment that provides suitable levels of flexibility? Discussion It is often tempting when specifying equipment to specify the fastest packaging lines.  Indeed, due to being pressured for ever increasing levels of efficiency, most packaging operations would...

Packaging Complexity Management Tip 16: Build flexibility into packaging equipment

Have you got the right type of packaging equipment that provides suitable levels of flexibility? Discussion It is often tempting when specifying equipment to specify the fastest packaging lines.  Indeed, due to being pressured for ever increasing levels of efficiency, most packaging operations would...

My latest column has just been posted with Pharma IQ.  To read it, please click here http://www.pharma-iq.com/business-development/columns/dealing-with-packaging-complexity/

November Column with Pharma IQ

My latest column has just been posted with Pharma IQ.  To read it, please click here http://www.pharma-iq.com/business-development/columns/dealing-with-packaging-complexity/

Have you designed your packaging to maximise the opportunities to deal with complexity? Discussion All of the different techniques we have discussed in these tips offer opportunities for dealing with low volume products and managing complexity but they may not be feasible with your...

Packaging Complexity Management Tip 15: Packaging design

Have you designed your packaging to maximise the opportunities to deal with complexity? Discussion All of the different techniques we have discussed in these tips offer opportunities for dealing with low volume products and managing complexity but they may not be feasible with your...

Can you late customise components and products? Discussion Our definition of late customisation is the physical modification of standard components and products to add features or information, making them product or market specific.  Examples would include on-line printing of content and over-labelling and may...

Packaging Complexity Management Tip 14: Late Customisation

Can you late customise components and products? Discussion Our definition of late customisation is the physical modification of standard components and products to add features or information, making them product or market specific.  Examples would include on-line printing of content and over-labelling and may...

Can you postpone customisation to as late as possible in the supply chain? Discussion There are a number of definitions of postponement, but the one we will use here is the delaying of customisation of a product until as late as possible in the...

Packaging Complexity Management Tip 13: Postponement

Can you postpone customisation to as late as possible in the supply chain? Discussion There are a number of definitions of postponement, but the one we will use here is the delaying of customisation of a product until as late as possible in the...

My latest column has just been posted with Pharma IQ.  To read it, please click here http://www.pharma-iq.com/regulatory-legal/columns/how-change-projects-succeed/

October Column with Pharma IQ

My latest column has just been posted with Pharma IQ.  To read it, please click here http://www.pharma-iq.com/regulatory-legal/columns/how-change-projects-succeed/

Andrew Love, VP Capability Development, Be4ward Ltd, will be presenting at HealthPack Europe 2013 which is taking place in Brussels on the 2nd – 4th December 2013. Andrew will be presenting on ‘Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities’. For more information...

Be4ward presenting at HealthPack Europe 2013

Andrew Love, VP Capability Development, Be4ward Ltd, will be presenting at HealthPack Europe 2013 which is taking place in Brussels on the 2nd – 4th December 2013. Andrew will be presenting on ‘Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities’. For more information...

Many thanks to Gabriela Zoren and the team at Global Leading Conferences for organising the 2nd Pharma Packaging and Labelling Forum 2013 that I chaired and spoke at in Vienna on the 19th and 20th of September.  It was a great event that was...

2nd Annual Pharma Packaging and Labelling Forum 19th-20th September NH Danube City, Vienna Global Leading Conferences

Many thanks to Gabriela Zoren and the team at Global Leading Conferences for organising the 2nd Pharma Packaging and Labelling Forum 2013 that I chaired and spoke at in Vienna on the 19th and 20th of September.  It was a great event that was...

My latest column has just been posted with Pharma IQ. To read it, please click here http://www.pharma-iq.com/regulatory-legal/columns/programme-management-considerations/

September Column with Pharma IQ

My latest column has just been posted with Pharma IQ. To read it, please click here http://www.pharma-iq.com/regulatory-legal/columns/programme-management-considerations/

Have you got processes to effectively manage order quantities of components and finished packs? Discussion Considering the previous tip on runners, repeaters and strangers, it is important to consider how volumes of components and finished products are managed through the supply chain. Packaging operations...

Packaging Complexity Management Tip 12: Manage order quantities of components and finished packs

Have you got processes to effectively manage order quantities of components and finished packs? Discussion Considering the previous tip on runners, repeaters and strangers, it is important to consider how volumes of components and finished products are managed through the supply chain. Packaging operations...

Do you have capability to supply product with different order and volume profiles – runners, repeaters and strangers? Discussion Products can be classified into three groupings: Runners: products that are produced very regularly. Repeaters: products that are produced or packed frequently, but not every...

Packaging Complexity Management Tip 11: Plan for runners, repeaters and strangers

Do you have capability to supply product with different order and volume profiles – runners, repeaters and strangers? Discussion Products can be classified into three groupings: Runners: products that are produced very regularly. Repeaters: products that are produced or packed frequently, but not every...

Are you maximising the opportunities to combine changes to minimise the frequency of changes to components? Discussion The concept of ‘bundling changes’ is the grouping of multiple different changes affecting the same pack or component together to change the pack only once. An analogy...

Packaging Complexity Management Tip 10: Bundle changes

Are you maximising the opportunities to combine changes to minimise the frequency of changes to components? Discussion The concept of ‘bundling changes’ is the grouping of multiple different changes affecting the same pack or component together to change the pack only once. An analogy...

Are you maximising the opportunities to share components or finished packs? Discussion Shared components and packs can provide a great opportunity to increase component and pack volumes.  However to make this happen it is necessary to identify markets and products that can successfully share...

Packaging Complexity Management Tip 9: Share components or packs

Are you maximising the opportunities to share components or finished packs? Discussion Shared components and packs can provide a great opportunity to increase component and pack volumes.  However to make this happen it is necessary to identify markets and products that can successfully share...

My latest column has just been posted with Pharma IQ.  To read it, please click here http://www.pharma-iq.com/regulatory-legal/columns/key-roles-for-artwork-improvement-projects/

August Column with Pharma IQ

My latest column has just been posted with Pharma IQ.  To read it, please click here http://www.pharma-iq.com/regulatory-legal/columns/key-roles-for-artwork-improvement-projects/

Are there defined standard fonts, illustrations, and graphical elements? Discussion Artwork content such as fonts, illustrations and other graphical content can provide hidden sources of complexity.  It is common for companies to build large ranges of content that needs to be stored, maintained and...

Packaging Complexity Management Tip 8: Minimise fonts, illustrations and graphical elements

Are there defined standard fonts, illustrations, and graphical elements? Discussion Artwork content such as fonts, illustrations and other graphical content can provide hidden sources of complexity.  It is common for companies to build large ranges of content that needs to be stored, maintained and...

Are there standard templates and layouts for artworks? Discussion Standardising the brand image, packaging artwork design and component sizes, permits the use of standard artwork templates and layouts. In this approach, global or regional templates can be created including all of the standard design...

Packaging Complexity Management Tip 7: Standardise artwork templates and layouts

Are there standard templates and layouts for artworks? Discussion Standardising the brand image, packaging artwork design and component sizes, permits the use of standard artwork templates and layouts. In this approach, global or regional templates can be created including all of the standard design...

My latest column has just been posted with Pharma IQ.  To read it, please click here http://www.pharma-iq.com/regulatory-legal/columns/making-it-happen-project-considerations-for-artwor/

July Column with Pharma IQ

My latest column has just been posted with Pharma IQ.  To read it, please click here http://www.pharma-iq.com/regulatory-legal/columns/making-it-happen-project-considerations-for-artwor/

I recently attended the IQPC Pharmaceutical and Labelling Summit in Basel.  As well as presenting on the topic of complexity management, I chaired Day 2.  Attached are my notes from the various speakers.   Best Practices on how to ensure Pharma Contact Packagers compliance...

Thoughts from the IQPC Pharmaceutical and Labelling Summit, Basel, 27 & 28 June 2013

I recently attended the IQPC Pharmaceutical and Labelling Summit in Basel.  As well as presenting on the topic of complexity management, I chaired Day 2.  Attached are my notes from the various speakers.   Best Practices on how to ensure Pharma Contact Packagers compliance...

Do you define and maintain a set of standard platform sizes? Discussion Components can come in multiple sizes and shapes and the challenge is how these can be controlled to an optimum number.  Your approach to this will be heavily impacted by your supply...

Packaging Complexity Management Tip 6: Control platform sizes

Do you define and maintain a set of standard platform sizes? Discussion Components can come in multiple sizes and shapes and the challenge is how these can be controlled to an optimum number.  Your approach to this will be heavily impacted by your supply...

Do you have a process to control the brand image and prevent unnecessary or undesirable proliferation of brand designs? Discussion It is not uncommon for companies to have a range of brand images that have arisen historically: Locally generated brand names and brand images....

Packaging Complexity Management Tip 5: Control brand variation

Do you have a process to control the brand image and prevent unnecessary or undesirable proliferation of brand designs? Discussion It is not uncommon for companies to have a range of brand images that have arisen historically: Locally generated brand names and brand images....

Is there a regular process to review the portfolio and prune unnecessary or non-performing SKUs? Discussion The performance of the portfolio is dynamic, changing due to many environmental and lifecycle factors.  Therefore a review process should ideally be performed on a routine and repeating...

Packaging Complexity Management Tip 4: Prune the portfolio regularly

Is there a regular process to review the portfolio and prune unnecessary or non-performing SKUs? Discussion The performance of the portfolio is dynamic, changing due to many environmental and lifecycle factors.  Therefore a review process should ideally be performed on a routine and repeating...

Do you have clear approval and control procedures for adding and removing SKUs from your portfolio? Discussion Firstly, do you have the appropriate cross-functional governance to ensure that all relevant impacted parties are engaged in the decision making and represented appropriately at a senior...

Packaging Complexity Management Tip 3: Clear approval and control processes for portfolio changes

Do you have clear approval and control procedures for adding and removing SKUs from your portfolio? Discussion Firstly, do you have the appropriate cross-functional governance to ensure that all relevant impacted parties are engaged in the decision making and represented appropriately at a senior...

Is the portfolio, volumes and lifecycles of your SKUs understood? Discussion The next step in a complexity reduction activity is a detailed understanding of the target SKU portfolio.  The scope of this may be certain brands, geographic areas, supply chains or perhaps your entire...

Packaging Complexity Management Tip 2: Understand the portfolio, volumes and lifecycle of SKUs

Is the portfolio, volumes and lifecycles of your SKUs understood? Discussion The next step in a complexity reduction activity is a detailed understanding of the target SKU portfolio.  The scope of this may be certain brands, geographic areas, supply chains or perhaps your entire...

My latest column has just been posted with Pharma IQ.  To read it, please click here http://www.pharma-iq.com/business-development/columns/making-it-happen-design-of-effective-change-manage/

June Column with Pharma IQ

My latest column has just been posted with Pharma IQ.  To read it, please click here http://www.pharma-iq.com/business-development/columns/making-it-happen-design-of-effective-change-manage/

Is the commercialisation strategy for the product and therapy and the subsequent value of complexity understood? Different products will have different requirements for the complexity of the packaging componentry and SKU portfolio. This can be driven from many factors, including but not limited to:...

Packaging Complexity Management Tip 1: Understand the product/therapy strategy and value of complexity

Is the commercialisation strategy for the product and therapy and the subsequent value of complexity understood? Different products will have different requirements for the complexity of the packaging componentry and SKU portfolio. This can be driven from many factors, including but not limited to:...

My latest column has just been posted with Pharma IQ. To read it, please click here http://www.pharma-iq.com/business-development/columns/making-it-happen-change-management-issues-in-artwo/

May Column with Pharma IQ

My latest column has just been posted with Pharma IQ. To read it, please click here http://www.pharma-iq.com/business-development/columns/making-it-happen-change-management-issues-in-artwo/

Andrew Love, VP Capability Development, Be4ward Ltd, will be presenting and hosting a workshop at IQPC’s  3rd Annual Pharmaceutical Packaging and Labelling conference which is taking place in Basel, Switzerland on the 27th-28th June 2013. Andrew will be presenting on ‘Top Tips for Complexity...

Be4ward presenting and hosting workshop at IQPC 3rd Annual Pharmaceutical Packaging and Labelling conference

Andrew Love, VP Capability Development, Be4ward Ltd, will be presenting and hosting a workshop at IQPC’s  3rd Annual Pharmaceutical Packaging and Labelling conference which is taking place in Basel, Switzerland on the 27th-28th June 2013. Andrew will be presenting on ‘Top Tips for Complexity...

In this series of articles I am going to discuss the topic of packaging complexity and outline a series of tips on approaches you can take to manage. So to start with, what is packaging complexity?  Many pharmaceutical companies have broad product portfolios that...

Dealing with Packaging Complexity

In this series of articles I am going to discuss the topic of packaging complexity and outline a series of tips on approaches you can take to manage. So to start with, what is packaging complexity?  Many pharmaceutical companies have broad product portfolios that...

My latest column has just been posted with Pharma IQ. To read it, please click here http://www.pharma-iq.com/logistics/articles/packaging-labelling-technology/

April Column with Pharma IQ

My latest column has just been posted with Pharma IQ. To read it, please click here http://www.pharma-iq.com/logistics/articles/packaging-labelling-technology/

In my first four articles in this series on change and programme management of artwork improvement projects, I talked about: some of the issues that need to be considered when setting up an artwork capability improvement programme some of the change management aspects to...

Programme Management considerations

In my first four articles in this series on change and programme management of artwork improvement projects, I talked about: some of the issues that need to be considered when setting up an artwork capability improvement programme some of the change management aspects to...

In my first three articles in this series on change and programme management of artwork improvement projects, I talked about some of the issues that need to be considered when setting up an artwork capability improvement programme, some of the change management aspects to...

Key roles for artwork improvement projects

In my first three articles in this series on change and programme management of artwork improvement projects, I talked about some of the issues that need to be considered when setting up an artwork capability improvement programme, some of the change management aspects to...

In my first two articles in this series on change and programme management of artwork improvement projects, I talked about some of the issues that need to be considered when setting up an artwork capability improvement programme and some of the change management aspects...

Project considerations for artwork improvement programmes

In my first two articles in this series on change and programme management of artwork improvement projects, I talked about some of the issues that need to be considered when setting up an artwork capability improvement programme and some of the change management aspects...

In my first article on this subject, ‘Change Management issues in artwork improvement programmes’, I talked about some of the issues that need to be considered when setting up an artwork capability improvement programme.  The cross-functional and cross-geographic nature of the process adds complexity...

Design of effective change management programmes for artwork improvement

In my first article on this subject, ‘Change Management issues in artwork improvement programmes’, I talked about some of the issues that need to be considered when setting up an artwork capability improvement programme.  The cross-functional and cross-geographic nature of the process adds complexity...

Last week I attended and spoke at the Fleming Europe 3rd Annual Pharma Packaging and Labelling Conference in Berlin.  There were a number of excellent presentations from a range of speakers. Present 1 – The implementation of anti-counterfeiting features in Pharma Packaging material.  ...

Fleming Europe 3rd Annual Pharma Packaging and Labelling Conference, 19-20 March, Berlin

Last week I attended and spoke at the Fleming Europe 3rd Annual Pharma Packaging and Labelling Conference in Berlin.  There were a number of excellent presentations from a range of speakers. Present 1 – The implementation of anti-counterfeiting features in Pharma Packaging material.  ...

Last week I had the privilege of being one of the judges for the Healthcare Compliance Packaging Council’s Columbus Award for Compliance Enhancing Packaging Design. Joining me on the judging panel were: Dr John Gill OBE FIET, John Gill Technology Ltd, UK Jan Geissler,...

Blog Heathcare Compliance Packaging Council Columbus Award

Last week I had the privilege of being one of the judges for the Healthcare Compliance Packaging Council’s Columbus Award for Compliance Enhancing Packaging Design. Joining me on the judging panel were: Dr John Gill OBE FIET, John Gill Technology Ltd, UK Jan Geissler,...

My latest column has just been posted with Pharma IQ.  To read it, please click here:   http://www.pharma-iq.com/manufacturing/columns/packaging-and-labelling-artwork-core-interfacing-a/

February Column with Pharma IQ

My latest column has just been posted with Pharma IQ.  To read it, please click here:   http://www.pharma-iq.com/manufacturing/columns/packaging-and-labelling-artwork-core-interfacing-a/

I have discussed a lot in previous blogs about causes, impacts and implications of artwork errors and the need to implement improvement programmes to address.  From our experience, what we see is that an artwork improvement programme is a complex inter-related set of activities,...

Change Management Issues in Artwork Improvement Programmes

I have discussed a lot in previous blogs about causes, impacts and implications of artwork errors and the need to implement improvement programmes to address.  From our experience, what we see is that an artwork improvement programme is a complex inter-related set of activities,...

How can we reduce administration errors through the effective introduction of unit dose packaging? A unit dose package can be described as a package that contains the particular dose of a drug for use by a specific patient in accordance to the patient’s specific...

Unit Dosing

How can we reduce administration errors through the effective introduction of unit dose packaging? A unit dose package can be described as a package that contains the particular dose of a drug for use by a specific patient in accordance to the patient’s specific...

My recent visit to the Pharma Packaging and Labelling Forum 2012 in Vienna got me thinking about how packaging can add value both to the patient and also to the bottom line. As an industry dedicated to the wellness of its customers, the issues...

Design of Packaging for Patient Safety

My recent visit to the Pharma Packaging and Labelling Forum 2012 in Vienna got me thinking about how packaging can add value both to the patient and also to the bottom line. As an industry dedicated to the wellness of its customers, the issues...

I am now writing a column ‘Artwork Matters: Excellence in Pharma Artwork’ for Pharma IQ a division of the International Quality and Productivity Centre (IQPC). To see my latest column, click here  http://www.pharma-iq.com/cold-chain/columns/packaging-labeling-tips-to-avoid-errors/

Latest Column with Pharma IQ

I am now writing a column ‘Artwork Matters: Excellence in Pharma Artwork’ for Pharma IQ a division of the International Quality and Productivity Centre (IQPC). To see my latest column, click here  http://www.pharma-iq.com/cold-chain/columns/packaging-labeling-tips-to-avoid-errors/

In the previous article on this topic, I discussed some pitfalls to consider if using the Commercial artwork process as a base-on for the Clinical Trials artwork process, and how it is essential to understand these sensitivities to ensure a suitable capability is provided....

Managing Clinical Trials Artwork 4: How to Develop Your Process

In the previous article on this topic, I discussed some pitfalls to consider if using the Commercial artwork process as a base-on for the Clinical Trials artwork process, and how it is essential to understand these sensitivities to ensure a suitable capability is provided....

Many thanks to Gabriela Zoren and the team at Global Leading Conferences for organising the Pharma Packaging and Labelling Forum 2012 that I spoke at in Vienna last September; it was a great event that was well attended. Whilst I was only able to...

Speech at Pharma Packaging and Labelling Forum 2012 in Vienna

Many thanks to Gabriela Zoren and the team at Global Leading Conferences for organising the Pharma Packaging and Labelling Forum 2012 that I spoke at in Vienna last September; it was a great event that was well attended. Whilst I was only able to...

In the previous article on this topic, I discussed some key considerations in using the Commercial artwork process as a base-on for the Clinical Trials artwork process. In doing this, it is essential to understand the differences required as there isn’t a ‘one size...

Managing Clinical Trial Artwork 3: Some Pitfalls to Avoid

In the previous article on this topic, I discussed some key considerations in using the Commercial artwork process as a base-on for the Clinical Trials artwork process. In doing this, it is essential to understand the differences required as there isn’t a ‘one size...

It is highly likely that one or more parts of your organisation are already working on this issue, perhaps in a coordinated way, perhaps not. Initially, we would recommend continuing this work until the appropriate course of action has been decided. We would recommend...

Managing Serialisation 9 – Where to start

It is highly likely that one or more parts of your organisation are already working on this issue, perhaps in a coordinated way, perhaps not. Initially, we would recommend continuing this work until the appropriate course of action has been decided. We would recommend...

Given the cross-functional and cross-organisational nature of the artwork capability, establishing the right inclusive leadership and governance is key to the long-term success of the capability. All stakeholder groups involved in the delivery of the artwork capability need to contribute effectively or the whole...

Excellent Packaging Artwork Capabilities 9 – Leadership and Governance

Given the cross-functional and cross-organisational nature of the artwork capability, establishing the right inclusive leadership and governance is key to the long-term success of the capability. All stakeholder groups involved in the delivery of the artwork capability need to contribute effectively or the whole...

Companies are faced with several specific issues when managing serialisation related legislation, these include: Identifying and interpreting the emerging and evolving legislation. Serialisation legislation, particularly in its early iterations, tends to be somewhat vague, incomplete and sometimes contradictory. Interpreting the legislation and predicting it’s...

Managing Serialisation 8 – What needs to be done

Companies are faced with several specific issues when managing serialisation related legislation, these include: Identifying and interpreting the emerging and evolving legislation. Serialisation legislation, particularly in its early iterations, tends to be somewhat vague, incomplete and sometimes contradictory. Interpreting the legislation and predicting it’s...

In the previous article on this topic, I discussed some key considerations in the development of an artwork process to support clinical trials . The clinical trials artwork process needs to deliver accurate and repeatable artwork in a fast changing and dynamic environment.  The...

Managing clinical trials artwork 2: opportunities to leverage the commercial artwork process

In the previous article on this topic, I discussed some key considerations in the development of an artwork process to support clinical trials . The clinical trials artwork process needs to deliver accurate and repeatable artwork in a fast changing and dynamic environment.  The...

Serialisation legislation will require new capabilities to be implemented across many different functions of a typical company. The more obvious impacts include: Packaging operations, where serialisation will have to be applied to product packaging at one or more levels. In the more complex serialisation...

Managing Serialisation 7 – Impacts of Serialisation

Serialisation legislation will require new capabilities to be implemented across many different functions of a typical company. The more obvious impacts include: Packaging operations, where serialisation will have to be applied to product packaging at one or more levels. In the more complex serialisation...

As we have discussed in earlier articles, creating correct artwork is an activity that requires many groups to act together in an orchestrated way to deliver a successful result, on time. The way of ensuring that these people act together in a co-ordinated way...

Excellent Packaging Artwork Capabilities 5 – The core artwork process

As we have discussed in earlier articles, creating correct artwork is an activity that requires many groups to act together in an orchestrated way to deliver a successful result, on time. The way of ensuring that these people act together in a co-ordinated way...

In the last article we talked about arguably the most complex of serialisation models, Track & Trace. In this article we will discuss some other aspects and the important topic of standards. Reverse and Abnormal Process Flows It should be noted that reverse product...

Managing Serialisation 5 – The Basics and Standards

In the last article we talked about arguably the most complex of serialisation models, Track & Trace. In this article we will discuss some other aspects and the important topic of standards. Reverse and Abnormal Process Flows It should be noted that reverse product...

As pressure to deliver new products intensifies in an increasingly complex regulatory environment, clinical trials are a vital endeavour for the pharmaceutical company.  If things go well, it will mean approval of the drug and potential revenue for the company.  However slight errors have...

Managing Clinical Trials Artwork 1: Some Key Considerations to Support Effective Trials

As pressure to deliver new products intensifies in an increasingly complex regulatory environment, clinical trials are a vital endeavour for the pharmaceutical company.  If things go well, it will mean approval of the drug and potential revenue for the company.  However slight errors have...

As we have discussed in earlier articles, creating correct artwork is an activity that requires many groups to act together in an orchestrated way to deliver a successful result, on time. The way of ensuring that these people act together in a co-ordinated way...

Excellent Packaging Artwork Capabilities 5 – The core artwork process

As we have discussed in earlier articles, creating correct artwork is an activity that requires many groups to act together in an orchestrated way to deliver a successful result, on time. The way of ensuring that these people act together in a co-ordinated way...

In the last article we talked about publishing serialisation information and the simplest of serialisation models, Authentication. In this article we will discuss arguably the most complex serialisation model, Track and Trace. Track & Trace Track and trace legislative models attempt to further improve...

Managing Serialisation 4 – The Basics and Track & Trace

In the last article we talked about publishing serialisation information and the simplest of serialisation models, Authentication. In this article we will discuss arguably the most complex serialisation model, Track and Trace. Track & Trace Track and trace legislative models attempt to further improve...

The development of packaging labelling and artwork involves many different groups across the company and, more often than not, external service providers and supply-chain partners. As we have already discussed, the creation of artwork requires many elements of information to be drawn together in...

Excellent Packaging Artwork Capabilities 4 – Service Culture

The development of packaging labelling and artwork involves many different groups across the company and, more often than not, external service providers and supply-chain partners. As we have already discussed, the creation of artwork requires many elements of information to be drawn together in...

In the last article we talked about the consequences of errors. In this article we will talk about some of the ways these errors occur, prior to discussing how to avoid them. Causes of artwork errors We have divided the many causes of artwork...

Excellent Packaging Artwork Capabilities 3 – The Causes of Errors

In the last article we talked about the consequences of errors. In this article we will talk about some of the ways these errors occur, prior to discussing how to avoid them. Causes of artwork errors We have divided the many causes of artwork...

In the last article we talked about unique identification and getting the unique identification onto the product or shipping unit. In this article we will discuss publishing the related serialisation information and one of the common serialisation models, Authentication. Product Information Notification Typically, once...

Managing Serialisation 3 – The Basics and Authentication

In the last article we talked about unique identification and getting the unique identification onto the product or shipping unit. In this article we will discuss publishing the related serialisation information and one of the common serialisation models, Authentication. Product Information Notification Typically, once...

In this article we will discuss the types of packaging labelling and artwork errors (which we refer to as “artwork errors”) that occur and their significant and far reaching impacts. This will provide context for later articles discussing the capabilities that need to be...

Excellent Packaging Artwork Capabilities 2 – Consequences of errors

In this article we will discuss the types of packaging labelling and artwork errors (which we refer to as “artwork errors”) that occur and their significant and far reaching impacts. This will provide context for later articles discussing the capabilities that need to be...

We will break serialisation legislative requirements down into four elements to help explain them: ● Unique Identification ● Product Information Notification ● Authentication ● Track & Trace In this article we will discuss the first of these, unique identification. Unique Identification All serialisation legislation...

Managing Serialisation 2 – The Basics and Unique Identification

We will break serialisation legislative requirements down into four elements to help explain them: ● Unique Identification ● Product Information Notification ● Authentication ● Track & Trace In this article we will discuss the first of these, unique identification. Unique Identification All serialisation legislation...

Pharmaceutical product serialisation legislation is being developed and approved across the World to ensure patient safety and prevent fraud. Achieving this across the supply chain is a major and very costly undertaking. Failure to comply with these legislative requirements will mean that pharmaceutical companies...

Managing Serialisation 1 – The situation in 2012

Pharmaceutical product serialisation legislation is being developed and approved across the World to ensure patient safety and prevent fraud. Achieving this across the supply chain is a major and very costly undertaking. Failure to comply with these legislative requirements will mean that pharmaceutical companies...

Hi everyone, we have just written a short paper that explains serialisation legislation, it’s impacts on an organisation and how to go about managing it. If you would like a copy, please contact me andrew and I will send you a free copy. We...

Do you need to know more about serialisation legislation and how to manage it?

Hi everyone, we have just written a short paper that explains serialisation legislation, it’s impacts on an organisation and how to go about managing it. If you would like a copy, please contact me andrew and I will send you a free copy. We...

Packaging artwork is an often forgotten back room process in most pharmaceutical companies, but the changing business environment has brought issues from this capability to the fore. Pharmaceutical and other healthcare companies are facing one of the most difficult periods in their history. Current...

Excellent Packaging Artwork Capabilities 1 – Why packaging artwork capabilities matter

Packaging artwork is an often forgotten back room process in most pharmaceutical companies, but the changing business environment has brought issues from this capability to the fore. Pharmaceutical and other healthcare companies are facing one of the most difficult periods in their history. Current...

Contact us and we will send you a copy while free stocks last! Our new book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities will launch mid-year, but we will soon have a limited number of free copies available. Delivering right first time packaging...

New book: Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities

Contact us and we will send you a copy while free stocks last! Our new book Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities will launch mid-year, but we will soon have a limited number of free copies available. Delivering right first time packaging...

All processes need governance to ensure they operate effectively within and across companies. Due to the potential significant impact of errors created by the artwork process on patients and the company, it would seem appropriate for the governance of the process to be at...

Artwork Auditor Tip 20 – Is there adequate cross functional / organisation governance in place?

All processes need governance to ensure they operate effectively within and across companies. Due to the potential significant impact of errors created by the artwork process on patients and the company, it would seem appropriate for the governance of the process to be at...

An artwork capability is a complex interaction of different tasks, people, functions, and organizations that must come together to produce a result which is correct in minute detail. The process has to do this in an environment of constantly evolving regulatory requirements and business...

Artwork Auditor Tip 19 – Is there an issue management and continuous improvement process in place?

An artwork capability is a complex interaction of different tasks, people, functions, and organizations that must come together to produce a result which is correct in minute detail. The process has to do this in an environment of constantly evolving regulatory requirements and business...

Many of the tasks involved in the end-to-end artwork process require a great deal of focus and attention to detail on the part of the individuals performing them. Some tasks also require specific tools to be able to them correctly. Consideration should be given...

Tip 18 – Do individuals have an appropriate working environment?

Many of the tasks involved in the end-to-end artwork process require a great deal of focus and attention to detail on the part of the individuals performing them. Some tasks also require specific tools to be able to them correctly. Consideration should be given...

A significant cause of error in artwork processes is a lack of adequate planning and resource level management. To be successful, many individuals from many different locations, functions and often companies need to play their part in the artwork process at the right time....

Artwork Auditor Tip 17- Is work planning and adequate resource level management in place?

A significant cause of error in artwork processes is a lack of adequate planning and resource level management. To be successful, many individuals from many different locations, functions and often companies need to play their part in the artwork process at the right time....

As we discussed in Tip 11, documents are likely to exist in a number of different formats and different individuals may need to deal with these different formats in different ways, e.g. images on screen, printouts. It is essential that everyone viewing a document,...

Artwork Auditor Tip 16 – Do all IT tools used during review and approval ensure the correct image is displayed?

As we discussed in Tip 11, documents are likely to exist in a number of different formats and different individuals may need to deal with these different formats in different ways, e.g. images on screen, printouts. It is essential that everyone viewing a document,...

Many Information Technology (IT) tools are often used to support a typical end-to-end artwork process. Examples would include: Artwork creation desktop Electronic proof reading tools Document management and electronic signature systems Workflow tools Barcode creation Verification tools As with any IT tools used to support...

Artwork Auditor Tip 15 – Are critical Information Technology tools managed under a Quality Management System?

Many Information Technology (IT) tools are often used to support a typical end-to-end artwork process. Examples would include: Artwork creation desktop Electronic proof reading tools Document management and electronic signature systems Workflow tools Barcode creation Verification tools As with any IT tools used to support...

Service providers such as external artwork studios and printers are often used by a company to make up their full artwork capability. Where 3rd parties are used to carry out patient and product safety related activity in the end-to-end process, a company needs to...

Artwork Auditor Tip 14 – Are service providers formally managed under a Quality Management System and subject to routine audits?

Service providers such as external artwork studios and printers are often used by a company to make up their full artwork capability. Where 3rd parties are used to carry out patient and product safety related activity in the end-to-end process, a company needs to...

Many of the tasks that need to be performed in the end-to-end artwork process rely heavily on the skill and competence of the operators. Particular examples of this would be artwork operators, proof readers and other document reviewers. Some operators are regularly involved in...

Artwork Auditor Tip 13 – Is ongoing education, training and competency assessment in place?

Many of the tasks that need to be performed in the end-to-end artwork process rely heavily on the skill and competence of the operators. Particular examples of this would be artwork operators, proof readers and other document reviewers. Some operators are regularly involved in...

We discussed the issue of ensuring that the evolution of a document is identified robustly in Tip 10. Having uniquely identified different versions of a document, the next thing to ensure is that everyone in the process is using the right version of a...

Artwork Auditor Tip 12 – Is everyone using the correct version of a document?

We discussed the issue of ensuring that the evolution of a document is identified robustly in Tip 10. Having uniquely identified different versions of a document, the next thing to ensure is that everyone in the process is using the right version of a...

We live in a world where we constantly deal with documents in different interchangeable formats. Rarely are the documents we deal with today created on paper, normally they are created electronically and shared using a number of different electronic and paper formats. Artwork and...

Artwork Auditor Tip 11 – Are there methods in place to ensure different forms of each document are the same?

We live in a world where we constantly deal with documents in different interchangeable formats. Rarely are the documents we deal with today created on paper, normally they are created electronically and shared using a number of different electronic and paper formats. Artwork and...

As with all document management activities, it is essential that everyone is clear which iteration of a document needs to be used at any particular time in the process. Many errors have occurred in artwork management processes because this has not been clear. For...

Artwork Auditor Tip 10 – Is there effective document version management in place?

As with all document management activities, it is essential that everyone is clear which iteration of a document needs to be used at any particular time in the process. Many errors have occurred in artwork management processes because this has not been clear. For...

In a Public Notice dated 22nd December 2012, the Indian Ministry of Commerce and Industry announced deferred dates for the requirements to serialise, track and trace Secondary and Primary level export product packaging. The revised dates are as follows and represent a delay of...

India delay Primary and Secondary export packaging serialisation requirements

In a Public Notice dated 22nd December 2012, the Indian Ministry of Commerce and Industry announced deferred dates for the requirements to serialise, track and trace Secondary and Primary level export product packaging. The revised dates are as follows and represent a delay of...

In a press release from ANVISA dated 8th December 2011, the results of the Brazil Government Integrated Task Force review of the serialisation legislation (Law No. 11.903/2009) were announced. An intention to implement full tracking of serialised product through the supply chain is still...

Brazil’s ANVISA update their serialisation track and trace requirements

In a press release from ANVISA dated 8th December 2011, the results of the Brazil Government Integrated Task Force review of the serialisation legislation (Law No. 11.903/2009) were announced. An intention to implement full tracking of serialised product through the supply chain is still...

An adequate audit trail should be maintained to ensure that it can be demonstrated that the process was carried out completely and correctly. It can also be beneficial to record additional information in the audit trail to assist with continuous improvement activities. For example,...

Artwork Auditor Tip 9 – Is an audit trail created and held for an appropriate period of time?

An adequate audit trail should be maintained to ensure that it can be demonstrated that the process was carried out completely and correctly. It can also be beneficial to record additional information in the audit trail to assist with continuous improvement activities. For example,...

In January 2013 securPharma are planning to start a medicines serialisation pilot designed to demonstrate the requirements of EU Directive 2011/62/EU in the German market. securPharma is a German organisation involving the whole German pharmaceutical supply chain in improving supply chain security. The pilot...

German serialisation pilot due to begin in January 2013

In January 2013 securPharma are planning to start a medicines serialisation pilot designed to demonstrate the requirements of EU Directive 2011/62/EU in the German market. securPharma is a German organisation involving the whole German pharmaceutical supply chain in improving supply chain security. The pilot...

It is important that checks are carried out to verify that changes to an artwork have been performed correctly and that no unintentional changes have been made by mistake. For this latter reason, we would recommend carrying out full checks at all verification steps,...

Artwork Auditor Tip 8 – Are there adequate quality checks performed at every document revision?

It is important that checks are carried out to verify that changes to an artwork have been performed correctly and that no unintentional changes have been made by mistake. For this latter reason, we would recommend carrying out full checks at all verification steps,...

In our opinion, ensuring that the roles and responsibilities are clear for the artwork process is important for a number of reasons. Firstly, it is critical that, where an individual needs to carry out tasks in the process, they are clear which specific tasks...

Artwork Auditor Tip 7 – Are roles and responsibilities clearly defined, especially at key control points?

In our opinion, ensuring that the roles and responsibilities are clear for the artwork process is important for a number of reasons. Firstly, it is critical that, where an individual needs to carry out tasks in the process, they are clear which specific tasks...

Having established the status, scope and critical controls of the artwork management process in the relevant Quality Management Systems, the next area to look at is the definition of the process activities themselves. Given the detailed nature of the artwork process and the fact...

Artwork Auditor Tip 6 – Is the overall process defined in a way which ensures complete and consistent working?

Having established the status, scope and critical controls of the artwork management process in the relevant Quality Management Systems, the next area to look at is the definition of the process activities themselves. Given the detailed nature of the artwork process and the fact...

We have encountered a number of occasions where errors occurred because the artwork that is initially developed and approved by the relevant stakeholders is not complete. Subsequent additions to the artwork, say to add product barcodes, create errors which are then not caught in...

Artwork Auditor Tip 5 – Is a complete version of the artwork created and approved?

We have encountered a number of occasions where errors occurred because the artwork that is initially developed and approved by the relevant stakeholders is not complete. Subsequent additions to the artwork, say to add product barcodes, create errors which are then not caught in...

We have observed many artwork errors occurring because the artwork process has continued despite the fact that a previous stage of the process has not been fully completed. A typical artwork change management process will divide the development of new or changed artwork, and...

Artwork Auditor Tip 4 – Are critical control points adequately defined?

We have observed many artwork errors occurring because the artwork process has continued despite the fact that a previous stage of the process has not been fully completed. A typical artwork change management process will divide the development of new or changed artwork, and...

One of the most basic causes of artwork error is not carrying out every change that is necessary as a result of a change trigger. For example, if a local regulator introduces a new packaging regulation requirement, one of the first questions that needs...

Artwork Auditor Tip 3 – Does a trigger for change result in all relevant artworks being changed?

One of the most basic causes of artwork error is not carrying out every change that is necessary as a result of a change trigger. For example, if a local regulator introduces a new packaging regulation requirement, one of the first questions that needs...

Once the existence of a Quality Management System (QMS) is established, the next thing to verify is that all artwork changes are managed within this framework. We have come across several situations where there was a good artwork capability in place, but unfortunately, it...

Artwork Auditor Tip 2 – Does the scope of the artwork management capability cover all labelling and artwork creation?

Once the existence of a Quality Management System (QMS) is established, the next thing to verify is that all artwork changes are managed within this framework. We have come across several situations where there was a good artwork capability in place, but unfortunately, it...

The packaging labelling and artwork management process in the healthcare industry creates an output which, if incorrect, can have serious implication on patient safety. Therefore, I would suggest that the artwork process must be managed under one or more formal Quality Management Systems (QMS)....

Artwork Auditor Tip 1 – Is the end-to-end artwork capability managed under a formal Quality Management System?

The packaging labelling and artwork management process in the healthcare industry creates an output which, if incorrect, can have serious implication on patient safety. Therefore, I would suggest that the artwork process must be managed under one or more formal Quality Management Systems (QMS)....

Today, large Pharmaceutical and other Healthcare companies are arguably in the midst of the toughest challenges that they have ever faced. These challenges include: Blockbuster drug patents are expiring at an alarming rate and product development pipelines are not ready to fill the ensuing...

Are Healthcare packaging labelling and artwork management capabilities key to meeting today’s business challenges?

Today, large Pharmaceutical and other Healthcare companies are arguably in the midst of the toughest challenges that they have ever faced. These challenges include: Blockbuster drug patents are expiring at an alarming rate and product development pipelines are not ready to fill the ensuing...