I attended and spoke at the IQPC Pharmaceutical Packaging and Labelling Summit 2015 in Zurich at the end of June. Many thanks to Ana Vulinovich and the team at IQPC for organising such a great and well attended event.
I presented on 10 Key Learnings from Artwork Improvement Projects. Taking the form of some top tips, this presentation covered some of the learnings we have had from our involvement in multiple artwork improvement projects, from how to set your project up for success, things to think about during the execution of your project and some pitfalls to avoid.
Other presentations I attended were:
Creating a High Performance, Cost Effective Packing Line
Carolina Sanchez-Cespedes, Head of Packaging, Eli Lilly.
Carolina spoke about the challenges faced at the Eli Lilly site in Spain due the changes in the marketplace that are creating increasing levels of packaging complexity. The resultant reduction on pack volumes has a knock on impact in line efficiency.
A comprehensive set it improvements looking at equipment, materials, processes, environment, systems, people and management has been undertaken supported by a range of operational excellence techniques. The improvements have reduced downtime by 20% and reduced levels of inventory.
Implementing a Change Management System to deliver Quality Artwork
Chika Umenyiora, QA Manager Artworks, Roche.
Chika presented on the implementation of a new artwork change management system in Roche. Rode had been having a number of labelling errors and this established the platform for the improvements required. A cross-functional team undertook a redesign of the artwork process, ensuring there were clear control points through the process. Requirements for each process step including data needed and responsibilities for task execution were clarified. This permitted a focus on getting activities completed right first time.
Artwork involves many people and the people change activities are as important as the technology and process improvements. Continued effort has been required to help people do the activities they need to do effectively and overcome the inevitable change management issues.
The project has significantly reduced issues with packaging artwork, provided improved oversight of the process and better co-operation between different departments.
The Hitchhikers Guide to Track and Trace
Marco Glauner, founder and Senior Consultant, Prime 4 services.
Marco presented on Prime4Services learnings on the implementation of Track and Trace solutions. This highlighted that whilst the major Pharma companies have comprehensive serialisation programs in place, there are many small to medium companies out there that haven’t started yet.
Also technology supplies are still learning the marketplace and don’t offer full, turnkey solutions. The solutions themselves are well developed but the service capability of suppliers is still developing. It is therefore important to select your partners carefully.
Developing a dear implementation strategy for each of your lines maximises the leverage of the investment required. Make sure you we only adding the capabilities you need to each line and rationalise your activities to manage the level of investment required.
Good serialisation Practices: Basics for a successful implementation
Dirk Hendrik Kneusels, Commercial Director, Antares Vision.
Hendrik presented on the requirements of software packages for track and trace. He explained the different system levels, who needs to be engaged by systems at each level and the key requirements at each Level. Hendrik then showed some of the Antares solutions and how they have built in the leanings from many applications they have completed. He also showed some manual solutions for warehousing and small volume activities where full automation is not viable. Finally Hendrik covered the range of documents and representation of people that are required to develop a strategy.
Developing an Open Architecture for Track and Trace
Marcel de Grutter, Business Technology Manager Operations, Abbott.
Marcel presented on the outcome from an industry roundtable group looking at the topic of an open architecture for Track and Trace. The roundtable concluded that a new standard for solutions is required, overseen by an industry governance group and appropriately resourced with suitable subject matter experts. The key benefits from this are reducing costs from the amount of repeated work required. Vendors also benefit through having common requirement templates and improved integration of solutions with other providers.
A steering committee is now in place and are starting to define the subject matter expert team. The group that has been established is Open-SCS Group. They are building links to other key groups e.g. Rx360. They are working on three phases to develop standards and standard URSs, OQ protocols etc.
Implementation of Adhesive Application for Tamper Evidence
Andreas Brandt, Business Development Manager, Baumer hhs GmbH.
Andreas presented on the legal aspects of tamper evidence, the solutions that were available and issues to corridor when selecting tamper evidence solutions. He showed the various examples of tamper evident solutions and focussed on the types of glue solutions. Using a combination of hot melt and cold glue gives the benefit of quick adhesion but without the risk of re-opening that you get with hot melt only.
Andreas highlighted that all products must have tamper evident features applied by 2018. The lead-time the get new tamper evidence equipment installed and products produced is short so it is an issue that needs to be addressed soon.
ROC 54/2013 – Looking at how Brazil interprets Track and Trace
Stefan Artlich, Director, Senior Project Manager, Product Tracking and Authentication, Bayer.
Stefan presented on the leanings Bayer had implementing Track and Trace in Brazil. There we many issues to be resolved:
- The size and scale of Brazil makes implementation challenging. There is a large infrastructure required.
- It is difficult getting local staff who speak English.
- The legislation currently expects that the manufacturers must maintain the repository of their data and communicate to Anvisa – this makes the IT requirements unique and complex.
- Wholesalers and retailers don’t want to communicate their data back to the Pharma Companies.
- The coding structure is complex and unique the Brazil.
- Legislation has been under development for a long time but the deadlines are imminent.
Serialisation – Constraint or Opportunity? Lessons learned after implementation at CMO level
David Da Cunha, Site Operations Manager, External Manufacturing Operations, Roche.
David presented on the implementation of serialisation into their CMOs. Rode has many CMOs and each are involved in the serialisation program. Rode has developed a serves of standards and requirements that their CMOs must meet and all CMOs must be serialisation ready by the end of 2015.
Roche provides financial and technical support to their CMOs but expect them to comply with the Roche requirements.
GS1 Perspective: Learnings from recent regulations
Christian Hay, Senior Consultant, GS1.
Christian presented on the latest learnings from GS1. He outlined the GS1 system of standards, and the requirements of FMD and the UDI legislation. He then reviewed a number at use cases from implementations of different legislations in different Pharma companies.
He also explained the communication activities that GS1 are doing to prepare markets for the introduction of datamatrix codes.
Working with a contract packaging organisation to meet emerging serialisation requirements
Gaurav Banerjee, Director Technical Services, Sharp Packaging Solutions.
Gaurav presented on activities that are being undertaken in Sharp to meet the needs of serialisation. Sharp have been involved in serialisation activity since 2008, serialising 2 billion packs for 25 Pharma companies.
Gaurav outlined the learnings they have had from the various implementations they have undertaken:
- How to deal with multiple customer systems.
- The need to keep line activities as standard as possible.
- The need to synchronise the material flows with the data flows.
- The modification to business processes including QA controls.
- The capital investments required for both IT systems and line equipment.
- New capabilities they have had to develop – project management skills, standard approaches and documentation, client integrations.
- Modification to artworks.
- The choosing of good technology partners.
Secured Serialisation with Authentication – the future of serialisation
James Lee, VP, Product Management, Systech.
James gave an overview of the global counterfeit marketplace and the impact on patients and the Pharma supply chain. He highlighted the issues associated with the multiple sets of legislation world-wide, both in terms of different requirements and timescales. Whilst most people see serialisation as an overhead, Jim looked at some of the opportunities in items of data provision.
Jim highlighted the leanings Systech have gained through their engagements:
- That regulations will continue to change.
- How do you handle errors and rework.
- How do you test your systems and interfaces?
- How to minimise the amount of manual work?
- How will you capture and manage your data?
Jim also emphasised that having a clear data model, across your extended network, is important to ensue standardisation and driving worst value. The application of field level authentication provides opportunity for end to end brand security.
Integrating IT and Automation Concepts for serialisation
Axel Jung, Product Management Track and Trace Systems, Laetus.
Axel presented on the different architectures that are needed for serialisation. He started with a simple single line implementation and expanded that through levels of complexity. This encompassed the introduction of level 4 ERP systems, multiple lines, warehousing and meeting different regulatory requirements.
He emphasised the need for flexibility and solutions that meet the needs of all stakeholders in the network. Priorities have also changed and the key things people are now looking for are integration capabilities into existing IT and production environments, and the level of local and global support. There is less emphasis on the purchase cost of the software.
Ensuring Patient Compliance via Packaging Design
Phill Marley, Packaging Intelligence, AstraZeneca.
Phill presented on their opportunities for improving patient compliance to their prescriptions through improved packaging. He highlighted a recent whitepaper from HCPC on ‘Patient friendly pharmaceutical pack design’.
Looking from the needs of the user, there are clear requirements for user-friendly design that make it easier for patients and healthcare providers to use the product. The HCPC white paper has a number of recommendations to enhance the user experience that are simple and easy to incorporate, but provide real benefit.
Understanding the Importance of Effective Information Communication to Patients and HCPs
Ruxandra Rogosca, Regulatory and Medical Affairs Manager, Reckitt Benckiser.
Ruxandra presented on the impact of packaging design and information provision on patents and healthcare providers. Communication is a key point – making sure that the materials being communicated comply with regulations, meeting ethical norms and the needs of the patient.
Advertising is to help the patent be well informed about their condition and comply with the regime. Advertising must comply with regulation, but requirements vary and are interpreted differently. Advertising should be truthful and not misleading.
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