I had the opportunity to attend, chair and present at the IQPC Pharmaceutical Packaging and Labelling Summit in Geneva on 22 and 23 June. Many thanks to Katherine Gordon, Daniella Ndeh and the team at IQPC for organising the event.
I presented on the importance of achieving artwork right-first-time and the impact that has on lead times and workload. I discussed a number of tips with practical examples on how companies can improve their artwork right-first-time and define a roadmap for their improvements.
The presentation can be accessed via the following link: Pharma Packaging and labeling IQ
Other presentations from the Artwork stream of the event included:
The Brazilian Heath Surveillance Agency (ANVISA) present an overview of their serialisation Requirements
Lisana Reginini Sirtori, Health Regulation Expert, Office of Packaging and Labelling of Drugs and Biological Products, Brazilian Health and Surveillance Agency (ANVISA)
Lisana presented on the challenges facing the labelling office in ANVISA. The regulatory framework in Brazil is evolving with new regulations awaiting approval by the ANVISA Directorate. These are expected to provide greater clarity on many aspects of labelling including Braille, age marking of products, presentation of Expiration Dates and Serialisation. There are likely to be impacts on both Rx and OTC products, but from Lisana’s perspective it was too early to say what these would be.
Lisana also highlighted a local issue regarding differentiation of products in Brazil. Many products are supplied by the Health Ministry and in the late 1990s, as a response to counterfeit medicines, the use of heavily standardised trade dress was introduced. This has resulted in little differentiation between many products in Brazil, a situation that the labelling team is hoping to resolve.
Artwork Asset Management and Workflow Technologies
Nadine Zimmermann, Artworks Specialist, Medinova
Nadine presented on the artwork management activities within Medinova. They supply 40 markets and have about 220 artwork projects per year. As is often the case, timelines are compressed and errors are costly so good coordination is required. This is achieved through use of ESKO’s WebCentre tool that allows all of the parties (including the CMOs) to be involved. All of the packaging information is held on the system and available to all.
WebCentre is used for collecting requirements and managing approvals. All of the projects can be managed by 1FTE. The next stage is introduction of the Artwork Editing capability.
Packaging and Labelling Management: How to avoid errors, recalls and minimise risk
Simon Cavanagh, Executive Account Brand Owner, ESKO/strong>
Simon presented on how to provide a seamless flow of information to the patient and how to align physical and digital assets to move to a single version of the truth. Product information is now available online as well as the traditional paper copy leaflets, etc. and to date most companies have built independent siloed operations to manage different parts of this information. This needs to be joined up. A single repository giving a single source of truth supported with the correct processes ensures that assets can be properly tracked from the beginning. Simon then presented on the ESKO organisation and the artwork software suite of tools they have developed.
Child Safety with Openability for Elderly People – An Impossible dream? Not when you get it right!
Stephen Wilkins, Chairman, Child-Safe Packaging Group
Children are intrinsically attracted to harmful products – this was confirmed in a study in the Netherlands last year. Stephen presented on two themes:
- How pharmaceutical packaging can be made safe for children and how child resistance testing is undertaken.
- The impact of child resistant packaging on the elderly and how the aging process affects us all in using our pharmaceutical products.
Stephen also gave an overview to current pertinent legislation and the development of new standards for openability and product testing.
The Need for Quality Management and Process Control in a Pharma Artwork Studio
Suzanne Ivory, Global Head of Quality, Perigord Premedia
Suzanne presented on the need for quality control in Artwork studios. Drawing on the experiences from Perigord, she discussed the need for a QMS covering the entire end-to-end artwork process and ensuring close relationships between the artwork studio and their customers, regardless of whether these are in-house or external. She highlighted that there are no GMP rules for artwork within the industry so many different approaches have been adopted. Also that the industry is not an early adopter of technology but needs to be careful it doesn’t miss out on the benefits technology can bring.
Suzanne emphasised the need for clear processes and unambiguous instructions, appraisal of service level agreements and metrics.
Life on the Sharp Edge of Anti-Counterfeiting Operations
Bawan Ahmed, Senior Pharmaceutical Assessor, Kurdistan Medical Control Agency
Bawan presented on the counterfeit market in Iraq in comparison to the rest of Middle East, Europe and the US. The Kurdistan region is an autonomous part of Iraq and has its own Medical Control Agency. There are 500 registered pharmacies and 6000 unregistered pharmacies which is an outcome of the many years of sanctions against Iraq. This informal supply base is uncontrolled, with pharmaceutical product being sold in market stalls, shops and even butchers! Product may be manufactured locally or imported and is shipped around the region in taxis. Bawan and his team are seeing around 1000 cases of counterfeit medicines a year but with only 5 staff in a dangerous and fluid environment, it difficult to police. The situation is improving through greater collaboration between enforcement parties and the pharmaceutical companies and improved training of staff.
Rajesh Lakshmanamoorthy, Manager, Operational Graphic Design, Novo Nordisk
Rajesh presented on artwork compliance within Novo Nordisk. 27 people are employed in the Novo Nordisk artwork centre in India which is part of the regulatory organisation. They have a standard global artwork process and Rajesh discussed how they control a number of topics to ensure the artwork supplied is accurate, for example barcodes, the quality of images and control of fonts. They have also developed comprehensive design manuals and shared repositories containing details of country specific requirements.
Implementing EU Variations on Time
Chika Jasmin Umenyiora, Global Quality Manager, Roche
Vasiliki Ntafi, Quality Manager for Artworks, Roche
Chika presented on the work that Roche have been doing to enhance their processes and systems to ensure safety updates are implemented on time. They have defined four scenarios for the phase-in and phase-out of components to cater for different market rules and different requirements for change. They have then established a number of checkpoints through the process to ensure that the artwork and production plans remain aligned.
Roche manage artwork execution in SAP so this allows them to monitor the execution of the end-to-end process across the supply chain.
Impact of the Implementation of the FMD for Packaging and Labelling
Maarten Van Baelen, Market Access Director, European Generic Medicines Association
The EGMA has been rebranded as Medicines for Europe – generics manufacturers are moving into other areas of the market so the branding of the organisation was becoming too restrictive.
Maarten presented on the latest status with the EMVO as part of the establishment of European-wide serialisation solution. Countries will need to establish national systems and the EMVO can provide support to this through the blueprint approach they have developed.
The payment model is being defined. MA holders will receive invoices from each relevant national system and the national systems will be billed from the central hub for use by the central hub. There will be a flat fee per MAH, so companies with many licenses will pay more.
A Patient-Centric Approach to Packaging: Involving Patients in a Longer Dialogue
Karel van der Waarde, Pharmaceuticals Consultant and Graphic Design Researcher
Karel’s presentation looked at medical packaging from the perspective of the patient. He looked at the design of packaging and the provision of information. Finding the right information is challenging due to the graphic design and layout of the text. He also showed how information provided can be misleading and in many cases doesn’t help the patient use the product properly or effectively.
Legislation exists and is supported by readability guidelines, but many products on the marketplace fall short of these. He proposed some simple improvements to the design of packaging, layouts and the provision of information that could have significant patient safety benefits.
A case study: using Wolke M600 OEM Thermal Ink Jet to offer a powerful track and trace solution
Heidi Vanheerswynghels, Global Strategic Account Manager, Videojet
Heidi presented a case study using a Wolke M600 OEM Thermal Ink Jet to offer a powerful track and trace solution. She gave a short overview of the FMD requirements and, in particular, the quality requirements for printing. These were used to develop the requirements for a printing solution that considered reliable performance, seamless integration, necessary data handling and appropriate productivity.
She explained why thermal ink jet has become the preferred coding method for track and trace, and emphasised the need to use equipment that is very flexible to provide opportunities to work with the space available on packing lines.
Ensuring Compliance – Top Regulatory Highlights to Focus on Right Now. European Standards for Pharmaceutical Packaging Tamper Verification Features
Dieter Mößner, Chairman of the, Packaging Standards Committee NAVp at the German Standards Institute DIN
Dieter presented on the work that is underway to define standards for tamper evidence as required by FMD. He explained that there is no mandate for the EU Commission to regulate the ant-tampering device in detail and that it is a decision of the manufacturer on which approach to use. The manufacturer must assure that the anti-tampering device is working at the point of dispense.
To support the application of anti-tampering devices a standard for tamper evidence (EN16679:2014) has been developed. Dieter walked through the standard and how it applies to various types of packaging and various tamper evidence solutions. He then discussed how you would go about implementation.
GS1 Discuss the FMD
Christian Hay, Senior Healthcare Expert, GS1
Christian discussed the GS1 standards and how they can help combat counterfeiting. GS1 standards underpin most serialisation and authentication solutions. He explained the requirements of authentication and traceability, and GS1’s involvement in the Joint Initiatives Council which is shaping solutions to the counterfeit drug challenge. He then discussed how medication management in the healthcare sector can operate using serialisation capabilities developed to GS1 standards. Christian discussed the development and content of the standard CEN ISO TS 16791 ‘Health informatics – Requirements for international machine-readable coding of medicinal product package identifiers’.
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