Stephen’s Blog

The countdown is well under way, with significantly less than 18 months until the EU Falsified Medicines Directive (EU FMD) serialisation compliance deadline – will your company be ready in time? With 32 countries across Europe being affected by this legislation, in this blog...

10 Tips to Accelerate your EU FMD Serialisation Strategy: Part 1

The countdown is well under way, with significantly less than 18 months until the EU Falsified Medicines Directive (EU FMD) serialisation compliance deadline – will your company be ready in time? With 32 countries across Europe being affected by this legislation, in this blog...

‘Driving Innovation and Technology in the Bio-pharma Supply Chain’ Bio Supply Management Alliance (BSMA) supports continuous learning and improvement of bio supply management professionals and the enhancement of the efficacy of the supply chain of the industry through collaboration. As Affiliate Members of BSMA,...

Join Be4ward at BSMA USA Supply Chain Management Forum, taking place on October 12, 2017 in Foster City, CA

‘Driving Innovation and Technology in the Bio-pharma Supply Chain’ Bio Supply Management Alliance (BSMA) supports continuous learning and improvement of bio supply management professionals and the enhancement of the efficacy of the supply chain of the industry through collaboration. As Affiliate Members of BSMA,...

A small number of key individuals in any project need to understand how both aspects are going to work. All too often, we see situations where nobody understands the overall picture at a sufficient level of detail, but many members of the team can...

Avoiding The Supply Risk From Serialisation With CMOs: Part 3

A small number of key individuals in any project need to understand how both aspects are going to work. All too often, we see situations where nobody understands the overall picture at a sufficient level of detail, but many members of the team can...

This is the second part of my Key Learnings on Avoiding The Supply Risk From Serialisation With CMOs. To see Part 1, please click here. Key learnings 7: Make sure you have sufficient Plan Bs Given the immature and evolving nature of serialisation and...

Avoiding The Supply Risk From Serialisation With CMOs: Part 2

This is the second part of my Key Learnings on Avoiding The Supply Risk From Serialisation With CMOs. To see Part 1, please click here. Key learnings 7: Make sure you have sufficient Plan Bs Given the immature and evolving nature of serialisation and...

For many Pharma companies, the use of contract manufacturing organisations (CMOs) to package commercial product is an integral part of their supply chain. Indeed, for virtual companies, it may be the only way their products are packaged. Serialisation legislation in the US, EU and...

Avoiding The Supply Risk From Serialisation With CMOs: Part 1

For many Pharma companies, the use of contract manufacturing organisations (CMOs) to package commercial product is an integral part of their supply chain. Indeed, for virtual companies, it may be the only way their products are packaged. Serialisation legislation in the US, EU and...

The global pharma market faces unprecedented complexities and pressures regarding the packaging and labelling of medicinal products. This guide examines the changes required for pharmaceutical packaging to meet the requirements of EU Falsified Medicines Directive (FMD) and the crucial questions to ask in order...

Be4ward Answer Crucial Questions Surrounding EU Falsified Medicines Directive (FMD) Pharma Artwork Compliance in Visual E-Guide

The global pharma market faces unprecedented complexities and pressures regarding the packaging and labelling of medicinal products. This guide examines the changes required for pharmaceutical packaging to meet the requirements of EU Falsified Medicines Directive (FMD) and the crucial questions to ask in order...

This the final instalment of a 3-part update on serialisation legislation developments since my last update in mid-2016. You can read Part 1 here and Part 2 here. If you want more detailed information and/or updates, I provide a legislation service which you can...

Global Pharma Serialisation Legislation Developments Roundup: Part 3

This the final instalment of a 3-part update on serialisation legislation developments since my last update in mid-2016. You can read Part 1 here and Part 2 here. If you want more detailed information and/or updates, I provide a legislation service which you can...

This the second of a 3-part update on serialisation legislation developments since my last update in mid-2016. To see Part 1, please click here. If you want more detailed information and/or updates, I provide a legislation service which you can subscribe to. Drop me...

Global Pharma Serialisation Legislation Developments Roundup: Part 2

This the second of a 3-part update on serialisation legislation developments since my last update in mid-2016. To see Part 1, please click here. If you want more detailed information and/or updates, I provide a legislation service which you can subscribe to. Drop me...

This is the first of a 3-part update on serialisation legislation developments since my last update in mid-2016. If you want more detailed information and/or updates, I provide a legislation service which you can subscribe to. Drop me an email for more details. Argentina...

New Global Pharma Serialisation Legislation Developments Roundup – Part 1

This is the first of a 3-part update on serialisation legislation developments since my last update in mid-2016. If you want more detailed information and/or updates, I provide a legislation service which you can subscribe to. Drop me an email for more details. Argentina...

Some companies seem to be understandably confused as to whether aggregation is required to meet the US DSCSA requirement. Indeed, the question came up again on a recent GS1 call this week. So let me try to help clarify the situation. Before I go...

Is aggregation required for US DSCSA serialization?

Some companies seem to be understandably confused as to whether aggregation is required to meet the US DSCSA requirement. Indeed, the question came up again on a recent GS1 call this week. So let me try to help clarify the situation. Before I go...

Join Be4ward and rfXcel Wednesday 16th November for an informative webinar. Click here to Register Today! We will address the November 2017 DSCSA serialization requirements for Contract Manufacturers (CMO’s). This session will help clarify some of the confusion Contract Manufactures are facing when it comes...

Join Be4ward and rfXcel for an informative webinar that will address the DSCSA compliance deadline

Join Be4ward and rfXcel Wednesday 16th November for an informative webinar. Click here to Register Today! We will address the November 2017 DSCSA serialization requirements for Contract Manufacturers (CMO’s). This session will help clarify some of the confusion Contract Manufactures are facing when it comes...

Oman has now published it’s “Barcoding System” requirements in Senate of Oman Ministry of Health requirement MH/DGMS/DSS/M/7043 dated 26/10/2016. The legislation is for pharmaceutical product sold into Oman under tender. The implementation timing is as follows: 31 December 2017:         GS1 Data Matrix containing GTIN,...

Oman publish serialisation requirements

Oman has now published it’s “Barcoding System” requirements in Senate of Oman Ministry of Health requirement MH/DGMS/DSS/M/7043 dated 26/10/2016. The legislation is for pharmaceutical product sold into Oman under tender. The implementation timing is as follows: 31 December 2017:         GS1 Data Matrix containing GTIN,...

I will be at the US Healthcare Distribution Alliance (formerly the HDMA), Traceability Event on 9th – 11th November, so hope to meet some of you there. As I discussed in my article about the recent FDA event the event is going to headline...

HDA Traceability Event, 9th – 11th November, Washington

I will be at the US Healthcare Distribution Alliance (formerly the HDMA), Traceability Event on 9th – 11th November, so hope to meet some of you there. As I discussed in my article about the recent FDA event the event is going to headline...

Don’t forget that we are holding another in the series of serialisation technology days with PCE Mettler Toledo, this time with IPT Ltd, Mettler Tolledo’s representatives in Cork, Ireland. The events we have done in the UK recently have been a resounding success and...

EU FMD serialisation event, Ireland

Don’t forget that we are holding another in the series of serialisation technology days with PCE Mettler Toledo, this time with IPT Ltd, Mettler Tolledo’s representatives in Cork, Ireland. The events we have done in the UK recently have been a resounding success and...

I was fortunate enough to have attended the latest in the FDA’s public meetings discussing the Drug Supply Chain Security Act (DSCSA). The focus of this specific event was to allow those impacted by the law to make representations on progress and share learning...

FDA Public Meeting key messages: Progress Toward Implementing the Product Identification Requirements of the DSCSA, 14th October 2016

I was fortunate enough to have attended the latest in the FDA’s public meetings discussing the Drug Supply Chain Security Act (DSCSA). The focus of this specific event was to allow those impacted by the law to make representations on progress and share learning...

As I have discussed previously, the US DSCSA legislation has a number of key dates for manufacturers who must serialise products: November 2019 to serialise the smallest saleable units and homogeneous cases, but notably no aggregation November 2023 to communicate this information to customers....

Emerging US DSCSA and wholesaler timelines and their implications

As I have discussed previously, the US DSCSA legislation has a number of key dates for manufacturers who must serialise products: November 2019 to serialise the smallest saleable units and homogeneous cases, but notably no aggregation November 2023 to communicate this information to customers....

We are holding another in the series of serialisation technology days with PCE Mettler Toledo, this time with IPT Ltd, Mettler Tolledo’s representatives in Cork, Ireland. The events we have done in the UK recently have been a resounding success and I am sure...

EU FMD Serialisation and Vision Inspection Technology day, Ireland

We are holding another in the series of serialisation technology days with PCE Mettler Toledo, this time with IPT Ltd, Mettler Tolledo’s representatives in Cork, Ireland. The events we have done in the UK recently have been a resounding success and I am sure...

I am pleased to let you know that ANVISA have now officially passed a resolution to suspend the deadlines for Brazilian pharmaceutical serialisation requirements in RDC54. There are, therefore, no residual Brazil serialisation deadlines pending. This means that the small residual risk that these...

Brazil’s ANVISA officially suspend 2016 deadlines

I am pleased to let you know that ANVISA have now officially passed a resolution to suspend the deadlines for Brazilian pharmaceutical serialisation requirements in RDC54. There are, therefore, no residual Brazil serialisation deadlines pending. This means that the small residual risk that these...

As ever, things are moving in the world of global serialisation legislation. Here are a few highlights from very recent activity. Brazil We are one step closer to the new PL4096 serialisation law being published as it has passed the constitutionality committee check. It...

Brazil, Russia & Taiwan serialisation update

As ever, things are moving in the world of global serialisation legislation. Here are a few highlights from very recent activity. Brazil We are one step closer to the new PL4096 serialisation law being published as it has passed the constitutionality committee check. It...

If you have not started addressing the US DSCSA serialization legislation, Be4ward’s accelerated serialization methodology and expertise might help you deliver what many believe is impossible in the time remaining. The November 2017 deadline for the initial implementation of US serialization legislation is fast...

It may not be too late to start addressing US DSCSA serialization

If you have not started addressing the US DSCSA serialization legislation, Be4ward’s accelerated serialization methodology and expertise might help you deliver what many believe is impossible in the time remaining. The November 2017 deadline for the initial implementation of US serialization legislation is fast...

It appears that Ali Health, who run the existing China serialisation electronic supervision system that issues serial numbers for Chinese product, have announced that they will be suspending the system. This follows the Chinese authorities suspending the current serialisation legislation requirements earlier this year,...

China – It’s Time to Stop Serialising for Now

It appears that Ali Health, who run the existing China serialisation electronic supervision system that issues serial numbers for Chinese product, have announced that they will be suspending the system. This follows the Chinese authorities suspending the current serialisation legislation requirements earlier this year,...

Not only have Brazil decided what to do about their President this week, but they have also made another significant step towards passing new serialisation legislation. This is good news because it means we are a relatively small step away from the current law,...

Brazil – Are we on the starting blocks again and is the end of 2016 risk over?

Not only have Brazil decided what to do about their President this week, but they have also made another significant step towards passing new serialisation legislation. This is good news because it means we are a relatively small step away from the current law,...

Algeria have now formally announced their new serialisation regulation, the details of which are emerging and should be published shortly. The good news is that discussions with the authorities at local and international events have shown that the Algerian authorities are very open to...

Algeria Update

Algeria have now formally announced their new serialisation regulation, the details of which are emerging and should be published shortly. The good news is that discussions with the authorities at local and international events have shown that the Algerian authorities are very open to...

I have had a lot of questions recently that boil down to the question of whether or not to aggregate product. So here are some thoughts about the things you need to consider… What do I mean by aggregation? First of all, let’s just...

Should you aggregate or not?

I have had a lot of questions recently that boil down to the question of whether or not to aggregate product. So here are some thoughts about the things you need to consider… What do I mean by aggregation? First of all, let’s just...

It’s been a long time since I did an update on serialisation legislation activity, so last week I did part one and this week is part two of a summary of some of the main things that are happening. If you want to know...

Recent serialisation legislation movements – Part 2

It’s been a long time since I did an update on serialisation legislation activity, so last week I did part one and this week is part two of a summary of some of the main things that are happening. If you want to know...

It’s been a long time since I did an update on serialisation legislation activity, so over the next two weeks I will give you a summary of some of the main things that are happening. If you want to know more details then just...

Recent serialisation legislation movements – Part 1

It’s been a long time since I did an update on serialisation legislation activity, so over the next two weeks I will give you a summary of some of the main things that are happening. If you want to know more details then just...

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...

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...

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...

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...

Define and agree some governing principles The next tip addresses developing and agreeing the key principles required to govern the life cycle of the serialisation capability. These principles should provide guidance for teams on what is permissible or not and would be approved and...

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 life cycle of the serialisation capability. These principles should provide guidance for teams on what is permissible or not and would be approved and...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

First of all let me say Happy New Year to you and, as my 85-year-old aunt always does, wish you “happiness and prosperity in abundance” in 2016. If you managed to get a break over the holiday period, I hope it refreshed you for...

Happy New Year and join me at a couple of January events

First of all let me say Happy New Year to you and, as my 85-year-old aunt always does, wish you “happiness and prosperity in abundance” in 2016. If you managed to get a break over the holiday period, I hope it refreshed you for...

I ran a workshop on global serialisation legislative requirements which seemed to get great reviews from the audience. Don’t forget that we offer a legislative update service, so if you need to stay up to date with serialisation legislation feel free to email me...

Some highlights from this week’s Pharmaceutical Traceability, Packaging & Labeling Forum in Boston

I ran a workshop on global serialisation legislative requirements which seemed to get great reviews from the audience. Don’t forget that we offer a legislative update service, so if you need to stay up to date with serialisation legislation feel free to email me...

Having received a lot of feedback, Russia have issued an updated version of their concept paper. It appears that some of the feedback has been taken into account, but the result is still a very complex implementation, with much detail still to be resolved....

Russia release updated serialisation concept paper

Having received a lot of feedback, Russia have issued an updated version of their concept paper. It appears that some of the feedback has been taken into account, but the result is still a very complex implementation, with much detail still to be resolved....

I’m looking forward to attending and leading a workshop session at the Pharmaceutical Traceability Forum next month, November 16-18 at the Boston Park Plaza. My workshop, “Global Serialization Legislation Update and Management” will be held on Monday, November 16. I’ll be joined with industry...

Pharmaceutical Traceability Forum Tackles Upcoming Regulations, Compliance Deadlines and Serialization Trends

I’m looking forward to attending and leading a workshop session at the Pharmaceutical Traceability Forum next month, November 16-18 at the Boston Park Plaza. My workshop, “Global Serialization Legislation Update and Management” will be held on Monday, November 16. I’ll be joined with industry...

  As I discussed in my last blog on the topic, the Ministry of Health in Russia has published a  draft federal drug traceability law. As you would hope, the likes of the Association of International Pharmaceutical Manufacturers (AIPM) have responded to the Russian...

Russian Draft Serialisation Requirements – the AIPM’s response

  As I discussed in my last blog on the topic, the Ministry of Health in Russia has published a  draft federal drug traceability law. As you would hope, the likes of the Association of International Pharmaceutical Manufacturers (AIPM) have responded to the Russian...

  The Ministry of Health in Russia has published a  draft federal drug traceability law, a Russian version of which is on the official website www.regulation.gov.ru. The draft law proposes to introduce a national electronic system to track product from manufacturer to end user,...

Russian Draft Serialisation Requirements – how will this evolve?

  The Ministry of Health in Russia has published a  draft federal drug traceability law, a Russian version of which is on the official website www.regulation.gov.ru. The draft law proposes to introduce a national electronic system to track product from manufacturer to end user,...

  Ok, so it came as no surprise, ANVISA “suspended” their serialisation dates for RDC-54/2013. Indications from local regulatory contacts indicate a delay of 3 years is on the cards, but who knows. Feeling of déjà vu anyone? This certainly isn’t our first time...

ANVISA delays again, how will this affect your team?

  Ok, so it came as no surprise, ANVISA “suspended” their serialisation dates for RDC-54/2013. Indications from local regulatory contacts indicate a delay of 3 years is on the cards, but who knows. Feeling of déjà vu anyone? This certainly isn’t our first time...

I had the pleasure of attending and presenting at this year’s PIMS Annual Packaging Innovation Leadership Summit last week. My presentation was about developing and sustaining labeling and artwork capabilities, a topic which I have blogged on many times and, of course, there is...

The Annual Packaging Innovation Leadership Summit

I had the pleasure of attending and presenting at this year’s PIMS Annual Packaging Innovation Leadership Summit last week. My presentation was about developing and sustaining labeling and artwork capabilities, a topic which I have blogged on many times and, of course, there is...

  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. Plan your updates. It is important...

Ensuring Effective Translations – Step 10: Securely store approved files and build 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. Plan your updates. It is important...

  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...

Ensuring Effective Translations – Step 9: 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...

  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...

Ensuring Effective Translations – Step 8: 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...

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 – Step 7: 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...

  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...

Ensuring Effective Translations – Step 6: 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...

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 – Step 5: 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...

Ensuring Effective Translations – Step 4: Choose a 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...

  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...

Ensuring Effective Translations – Step 3: 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...

  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...

Ensuring Effective Translations – Step 2: 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...

  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...

Ensuring Effective Translations – Step 1: Define your approach to 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...

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...

  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...

Next June 18th, Be4ward will be speaking at the lunch & learn event Strategies for Pursuing Labeling & Artwork Excellence. We would love to have you join our session. Please click on the image below to register for this event. We look forward to having...

Leaders in Labeling – Lunch & Learn Webinar Invite

Next June 18th, Be4ward will be speaking at the lunch & learn event Strategies for Pursuing Labeling & Artwork Excellence. We would love to have you join our session. Please click on the image below to register for this event. We look forward to having...

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 miss...

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 miss...

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 therefore...

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 therefore...

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 place....

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 place....

In April, the S.Korea Pharmaceutical Information Center (KPIS), held training sessions that described the new requirements for serialisation track and trace in S.Korea, which are intended to come in to force 1st January 2016. In a recent meeting with KPIS, they emphasized that the...

South Korea serialisation track & trace 1st January 2016

In April, the S.Korea Pharmaceutical Information Center (KPIS), held training sessions that described the new requirements for serialisation track and trace in S.Korea, which are intended to come in to force 1st January 2016. In a recent meeting with KPIS, they emphasized that the...

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. Impacts...

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. Impacts...

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 expanding...

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 expanding...

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 and...

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 and...

Last week I introduced my new blog topic for the next few weeks; important tips that are intended to help guide you while undertaking your new serialisation program or project. Serialisation is a cross-functional, and in many cases in a typical pharmaceutical company, cross-organisation...

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

Last week I introduced my new blog topic for the next few weeks; important tips that are intended to help guide you while undertaking your new serialisation program or project. Serialisation is a cross-functional, and in many cases in a typical pharmaceutical company, cross-organisation...

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...

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

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 spoke at in early March, below are the remainder of the highlights that I thought may interest you. Again, many thanks to Mukesh Shant...

I attended and spoke 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 spoke 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...

We attended the 7th Annual Pharma Packaging and Labeling USA 2015 conference in Philadelphia a couple of weeks ago and thought you might be interested in a few of the key messages that we took away from it. The event essentially covered three topics...

Interesting topics from the 7th Annual Pharma Packaging and Labeling USA 2015, Philadelphia

We attended the 7th Annual Pharma Packaging and Labeling USA 2015 conference in Philadelphia a couple of weeks ago and thought you might be interested in a few of the key messages that we took away from it. The event essentially covered three topics...

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...

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...

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...

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...

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...

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here: http://www.pharmaceuticalonline.com/doc/dealing-with-packaging-complexity-tips-to-0004

January Column with Pharmaceutical Online

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here: http://www.pharmaceuticalonline.com/doc/dealing-with-packaging-complexity-tips-to-0004

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...

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here: http://www.pharmaceuticalonline.com/doc/dealing-with-packaging-complexity-tips-to-0003

December Column with Pharmaceutical Online

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here: http://www.pharmaceuticalonline.com/doc/dealing-with-packaging-complexity-tips-to-0003

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...

Serialisation legislation will require new capabilities to be implemented across many differ­ent functions of a typical company. The most obvious include: Regulatory and legislative management and government affairs who will have to understand new emerging requirements and represent the company in external in­fluencing and...

10 tips for developing a serialisation strategy – Introduction

Serialisation legislation will require new capabilities to be implemented across many differ­ent functions of a typical company. The most obvious include: Regulatory and legislative management and government affairs who will have to understand new emerging requirements and represent the company in external in­fluencing and...

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here: http://www.pharmaceuticalonline.com/doc/dealing-with-packaging-complexity-tips-to-0002

November Column with Pharmaceutical Online

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here: http://www.pharmaceuticalonline.com/doc/dealing-with-packaging-complexity-tips-to-0002

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...

Artwork Auditor 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...

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here: http://www.pharmaceuticalonline.com/doc/dealing-with-packaging-complexity-tips-5-to-8-0001

October Column with Pharmaceutical Online

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here: http://www.pharmaceuticalonline.com/doc/dealing-with-packaging-complexity-tips-5-to-8-0001

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...

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here: http://www.pharmaceuticalonline.com/doc/dealing-with-packaging-complexity-tips-to-0001

September Column with Pharmaceutical Online

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here: http://www.pharmaceuticalonline.com/doc/dealing-with-packaging-complexity-tips-to-0001

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...

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here   http://www.pharmaceuticalonline.com/doc/dealing-with-packaging-complexity-0001

August Column with Pharmaceutical Online

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here   http://www.pharmaceuticalonline.com/doc/dealing-with-packaging-complexity-0001

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...

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,...

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...

May Column with Pharmaceutical Online My latest column has just been posted with Pharmaceutical Online.  To read it, please click here  http://www.pharmaceuticalonline.com/doc/how-change-projects-succeed-0001        

How Change Projects Succeed

May Column with Pharmaceutical Online My latest column has just been posted with Pharmaceutical Online.  To read it, please click here  http://www.pharmaceuticalonline.com/doc/how-change-projects-succeed-0001        

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)....

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....

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here  http://www.pharmaceuticalonline.com/doc/packaging-and-labeling-program-management-considerations-0001

May Column with Pharmaceutical Online

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here  http://www.pharmaceuticalonline.com/doc/packaging-and-labeling-program-management-considerations-0001

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...

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...

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here http://www.pharmaceuticalonline.com/doc/making-it-happen-key-roles-for-artwork-improvement-projects-0001.  

April Column with Pharmaceutical Online

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here http://www.pharmaceuticalonline.com/doc/making-it-happen-key-roles-for-artwork-improvement-projects-0001.  

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...

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...

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...

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...

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...

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here: http://www.pharmaceuticalonline.com/doc/making-it-happen-project-considerations-for-artwork-improvement-programs-0001.  

March Column with Pharmaceutical Online

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here: http://www.pharmaceuticalonline.com/doc/making-it-happen-project-considerations-for-artwork-improvement-programs-0001.  

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...

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...

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here: http://www.pharmaceuticalonline.com/doc/packaging-and-labeling-design-of-effective-change-management-programs-for-artwork-improvement-0001.  

January Column with Pharmaceutical Online

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here: http://www.pharmaceuticalonline.com/doc/packaging-and-labeling-design-of-effective-change-management-programs-for-artwork-improvement-0001.  

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...

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...

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here http://www.pharmaceuticalonline.com/doc/packaging-and-labeling-change-management-issues-in-artwork-improvement-programs-0001.

January Column with Pharmaceutical Online

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here http://www.pharmaceuticalonline.com/doc/packaging-and-labeling-change-management-issues-in-artwork-improvement-programs-0001.

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 week or...

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 week or...

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...

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...

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 Pharmaceutical Online.  To read it, please click here: http://www.pharmaceuticalonline.com/doc/packaging-and-labeling-technology-0001.

November Column with Pharmaceutical Online

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here: http://www.pharmaceuticalonline.com/doc/packaging-and-labeling-technology-0001.

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...

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here http://www.pharmaceuticalonline.com/doc/packaging-and-labelling-organisation-and-governance-0001

October Column with Pharmaceutical Online

My latest column has just been posted with Pharmaceutical Online.  To read it, please click here http://www.pharmaceuticalonline.com/doc/packaging-and-labelling-organisation-and-governance-0001

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 Pharmaceutical Online. To read it, please click here: www.pharmaceuticalonline.com/doc/packaging-and-labelling-artwork-core-interfacing-and-supporting-processes-0002/

September Column with Pharmaceutical Online

My latest column has just been posted with Pharmaceutical Online. To read it, please click here: www.pharmaceuticalonline.com/doc/packaging-and-labelling-artwork-core-interfacing-and-supporting-processes-0002/

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:...

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...

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,...

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...

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...

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 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...

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 Proof Reading 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...

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 Proof Reading 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 Proof Reading 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 Proof Reading 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...

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 Proof Reading 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 finisher. Ability to concentrate on a task for long...

Causes of Proof Reading 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 finisher. Ability to concentrate on a task for long...

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 Proof Reading Errors 9 – Not using checklists 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,...

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 Proof Reading 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 Proof Reading 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 Proof Reading 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...

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 Proof Reading 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 Proof Reading 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...

Andrew Love and I attended this excellent conference and ran a half day workshop on the subject of ‘Setting up for success in Serialisation – Beat the deadlines’. Click here to find out more about the conference.

IQPC Pharmaceutical Serialisation and Traceability Summit 2012, Geneva 13-14 November

Andrew Love and I attended this excellent conference and ran a half day workshop on the subject of ‘Setting up for success in Serialisation – Beat the deadlines’. Click here to find out more about the conference.

We are publishing a series of articles in the well-respected subscription publication GMP Review, the first of which appeared in the quarter four 2012 edition. To see these articles and many other helpful GMP review related information follow this link.

See our latest article in GMP Review

We are publishing a series of articles in the well-respected subscription publication GMP Review, the first of which appeared in the quarter four 2012 edition. To see these articles and many other helpful GMP review related information follow this link.

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 Proof Reading 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...

To gain support for improvement in any area of business, it is critical that the appropriate group of senior stakeholders understand the area sufficiently well to be able to take appropriate and timely decisions. In a previous article How big a risk is your...

Are your senior management equipped to make effective decisions about your packaging labelling and artwork capability?

To gain support for improvement in any area of business, it is critical that the appropriate group of senior stakeholders understand the area sufficiently well to be able to take appropriate and timely decisions. In a previous article How big a risk is your...

Many thanks to Alan Reynolds and the team at CAPDM for inviting me to speak to them about global trends in product coding and serialization. I had the pleasure of presenting to about seventy of the CAPDM members a couple of weeks ago in...

Serialization with the Canadian Association for Pharmaceutical Distribution Management

Many thanks to Alan Reynolds and the team at CAPDM for inviting me to speak to them about global trends in product coding and serialization. I had the pleasure of presenting to about seventy of the CAPDM members a couple of weeks ago in...

Errors in packaging labelling and artwork presents a significant compliance and reputation risk to pharmaceutical and medical device companies, a topic which I have explored in a previous blog article . Here I will discuss how to assess your end-to-end capabilities in this area,...

How big a risk is your packaging labelling and artwork capability?

Errors in packaging labelling and artwork presents a significant compliance and reputation risk to pharmaceutical and medical device companies, a topic which I have explored in a previous blog article . Here I will discuss how to assess your end-to-end capabilities in this area,...

Technology is a necessary and useful part of any packaging labelling and artwork capability, indeed it is practically impossible to operate an artwork capability today without some elements of technology. Technology helps address many issues which can lead to improvements in compliance, performance and...

Excellent Packaging Artwork Capabilities 10 – Technology

Technology is a necessary and useful part of any packaging labelling and artwork capability, indeed it is practically impossible to operate an artwork capability today without some elements of technology. Technology helps address many issues which can lead to improvements in compliance, performance and...

Many thanks to Anna Fraenkel and the team at IQPC for organising this year’s Packaging and Labelling Summit in Basel, it was a great event that was well attended. I have pulled out a few my highlights of the event below. Book launch and chairing...

IQPC Packaging and Labelling Summit 2012

Many thanks to Anna Fraenkel and the team at IQPC for organising this year’s Packaging and Labelling Summit in Basel, it was a great event that was well attended. I have pulled out a few my highlights of the event below. Book launch and chairing...

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...

Having discussed the various types of processes associated with packaging labelling and artwork capabilities, I will now discuss some aspects related to organisation design. Roles that support the process Roles should be structured to support the business process. Therefore you need to have defined...

Excellent Packaging Artwork Capabilities 8 – Organisation design

Having discussed the various types of processes associated with packaging labelling and artwork capabilities, I will now discuss some aspects related to organisation design. Roles that support the process Roles should be structured to support the business process. Therefore you need to have defined...

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...

The core processes described in a previous article defines how individual labelling and artwork changes will be carried out. Whilst this is absolutely critical to the success of the artwork capability in an organisation, it is not sufficient in itself to provide a complete...

Excellent Packaging Artwork Capabilities 7 – Supporting Processes

The core processes described in a previous article defines how individual labelling and artwork changes will be carried out. Whilst this is absolutely critical to the success of the artwork capability in an organisation, it is not sufficient in itself to provide a complete...

In the last article we discussed the core labelling and artwork processes. In this article we will discuss some of the processes which interface with these core processes. The artwork process does not operate in isolation. It is a process which relies on information...

Excellent Packaging Artwork Capabilities 6 – Interfacing Processes

In the last article we discussed the core labelling and artwork processes. In this article we will discuss some of the processes which interface with these core processes. The artwork process does not operate in isolation. It is a process which relies on information...

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...

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...

Thanks to ExLPharma and the presenters for organising the serialisation conference last week in Philidelpia and “hi” to all those who attended. For those that did not attend, I thought I would share some headlines which resonated for me as someone who had been...

Some highlights from last week’s 2012 2nd Life Sciences Serialization & Traceability For Brand Protection Conference

Thanks to ExLPharma and the presenters for organising the serialisation conference last week in Philidelpia and “hi” to all those who attended. For those that did not attend, I thought I would share some headlines which resonated for me as someone who had been...

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...

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...

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...

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...

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 stephen.mcindoe@be4ward.com and I will send you a free copy. We will...

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 stephen.mcindoe@be4ward.com and I will send you a free copy. We will...

———————————————————- —————————————————————– 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 be launched mid-year, but we will soon have a limited number of free copies available. Delivering...

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 be launched mid-year, but we will soon have a limited number of free copies available. Delivering...

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...

Artwork Auditor 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...

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...

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 6...

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 6...

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...

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...