IQPC Pharmaceutical Packaging and Labelling conference in Basel
I spent a few days last week at the IQPC pharmaceutical Packaging and labelling conference in Basel.
A big thank you to Anastasia, Michael, Gerald and the team at IQPC for organising another excellent conference.
Key highlights included:
World Customs Organisation: The Global Approach to Combat Counterfeits.
Benoit Goyens, World Trade Organisation
The first presentation was by Benoit Goyens at the World Customs Organisation. Benoit discussed the IPM tool, a tool to foster collaboration between customs officers and rights holders. The tool allows a significant amount of information on products, supply routes etc. to be held and be available to customs officers. It also provides a repository for previous incidents for reference. The tool has been rolled out to 74 countries and deployment continues. A smartphone app has also been developed to allow customs officers to access information in the field. Deployment continues with more countries being added and the development of future functionality, for example the incorporation of authentication.
Latest Developments around the European Medicines Verification System, EMVS
Marcel De Grouter, Abbott
Marcel provided an update on the progress of the European Stakeholder Model and the deployment of FMD and the EMVS. The EMVS is targeted to go live in 2014 and work progresses with securPharm in Germany to make this happen. Ramp up is expected from 2015 through 2018. This is partially dependent upon the publication of the delegated acts in Q1 2015.
Practical examples for T&T from all over the world
Hendrik Kneusels, Antares Vision
Hendrick shared examples of projects that Antares Vision has been involved in the learnings they have gained from those projects. Items such as the involvement of many functions across the organisation, redesign of packaging materials to work effectively with printing and reading capabilities on the lines and the hierarchy of IT solutions required were discussed.
Hendrick also discussed how the ongoing development of new tools required for serialisation can restore operations to levels of OEE witnessed before.
Ensuring accurate and on-time packaging artwork in an ever more complex Global Regulatory Environment
Andrew Love, Be4ward
I facilitated a team discussion session on labelling and artwork issues. In four groups, the conference participants discussed one of four questions:
- What are the impacts on patients and healthcare professionals when artwork errors arise?
- What types of error could occur and how could they be prevented?
- What capabilities do Pharma companies need to ensure accurate and timely artwork production?
- How can suppliers and technology ensure accurate artwork?
We then shared key points from these discussions.
Pharmaceutical Products integrity and Authenticity as essential requirements of the FDM 2011/62/UE
Andrea Dellepiane, Pilot Italia S.p.A.
Andrea discussed the requirements of FMD and the different solution required for serialisation, anti-counterfeiting and tamper evidence and how the three topics need to be considered together to protect the patient. Andrea also discussed the developing European standard for tamper evidence and the different types of sealing technology available.
Exclusive insight into Generics and the Packaging Industry
Maarten Van Baelen, EGA – European Generics Medicines Association
Maarten updated the audience on the Generic Pharmaceutical industry and the impacts and position of the Generics industry to the FMD legislation. He outlined the generics companies concerns regarding the cost of implementation of FMD, the impact on product profitability and line efficiency and the risks to supply during implementation. The challenges associated with an EU-wide risk assessment and cost allocation were also highlighted.
Tamper Evidence for pharmaceutical packaging
Andreas Brandt, Baumer HHS
Andreas presented on the regulations, standards and solutions available for the tamper evidence requirements of FMD. He discussed the opportunities and challenges associated with different types of adhesives. He also highlighted the timelines required to implement tamper evident solutions and the need to be starting soon!
Best Practice approaches to Lean Transformation in Pharmaceutical packaging
Klaus Hjortgaard Olsen, Lundbeck
Klaus presented on the improvements that have been made in his packaging operations through the application of lean techniques across the organisation. This has been a significant journey for the company and a significant cultural change. He also outlined the programme that Lundbeck is going through. The programme has freed so much capacity that they have been able to bring back In house product packaging that was undertaken at CMOs whilst also seeing a significant increase in product range.
Information about medicines: What patients get to see?
Karel van der Waarde, Pharmaceutical Consultant and Graphic Design Researcher
Karl presented on the patient safety aspects of packaging. In particular, he looked at the impact of legislation, which is often defined to support manufacturers and distributors, on end users especially the elderly. He discussed the implications of tamper evidence on openability and what companies should be considering to improve the patients’ use of packaging
Optimising Product Information on Packaging: Optimising Information on a reduced surface area
Catherine Libilbéhéty, Sanofi
Catherine talked about the growing requirements for information to be provided on packaging and the challenge of available space. She gave an overview of the European labelling regulations and some of the techniques she has used to address the challenges for space. She also outlined the opportunity for the incorporation of QR Codes on pharmaceutical packaging and the implications these may present.
Leaflet Paper: A genuine speciality paper market
Keith Rousell, Bolleré Thin Papers
Keith talked us through the developments underway in the paper industry. He discussed the types and uses of different types of paper and the characteristics that are important for the applications in the pharma industry. He also discussed the changes in technology that are providing new opportunities e.g. digital printing, and the industry requirements and Bolleré’s response to sustainability.
Managing product packaging complexity in a global marketplace
Andrew Love, Be4ward Ltd
I presented on the challenges increasing product ranges are creating for product packaging and some of the opportunities for managing this complexity.
Integrated IT and Automation Concepts for Serialisation and Product Tracking
Christoph Staub, Laetus Group
Christoph presented on the IT requirements for serialisation. He covered the architecture required from the line level to the corporate layer, the capabilities needed at each level and how to ensure a flexible architecture is implemented. He also highlighted the growing importance of integration capability as solutions extend across the supply chain and multiple systems/partners.
Packaging Design to help improve Patient Compliance
Hinrik Petursson, Actavis
Hinrik presented on how packaging design can improve the patient’s adherence to their regime. He looked at some of the reasons behind poor adherence why it is important that adherence is improved. He reviewed a number of packaging design techniques for different dose forms that can help raise adherence and monitoring devices available to warn when medicines should be taken.