Thomas Brückner, BPI (German Pharmaceutical Industry Association)
Maren Göpfert, Boehringer Ingelheim Pharma
Horst Kastrup, Senior Expert, Germany
Dieter Mößner, Edelmann GmbH
Dr Stephan Schwarze, Bayer AG
Wilfried Weigelt, REA Elektronik GmbH
It is the course’s goal to inform about the latest developments in serialisation & authentication coming from the EU directive 2011/62/EC and the corresponding Delegated Regulation as published in the Official Journal of the European Union. Best practice examples will demonstrate how the new European requirements on verification of the authenticity of each single medicinal product can be put into practice.
Directive 2011/62/EC also known as “EU Falsified Medicine Directive” came into force already in 2011. Not before October 2015, the final draft of the corresponding Delegated Regulation was made known to the public following the adoption by the EU Commission.
Finally, by 9th February 2016 the “Commission Delegated Regulation (EU) 2016/161” “supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use” was published in the Official Journal of the European Union. As consequence, the rules will be applied from 9th of February 2019 onwards except for some member states with an existing Verification System.
Furthermore recognizing that some of the defined rules need further interpretation several Question and Answer documents, recently Version 7 were published to provide guidance.
In addition, the EMA has just updated on 29 June 2017 the Implementation Plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human use confirming the implementation date of 9th of February 2019.
Like many of such regulation it is burdensome to read through these documents and sometimes it is also challenging to capture the relevant content. Key for a successful implementation of the applicable regulation is the understanding of what is really in there for you and what is actually relevant.
The training course will support you in collecting, sorting and proper understanding of the relevant contained information related to the defined safety features, which are
- a unique identifier and
- tamper evident closures
within the EU. The German Initiative “securPharm” is the only system in the EU which is in compliance with the published delegated regulation that has already been implemented successfully. A report about the current status is part of the training course. Beyond this an insight in the current global landscape of serialisation and coding requirements and system is provided as well.
Practical examples will be presented and further discussed in corresponding workshops during this training course dealing with questions like:
- What is the impact of the delegated regulations for the safety features in the EU on the pharmaceutical industry?
- What does coding and serialisation mean for manufactures of printed packaging material?
- How is the code quality defined and how to test the appropriate code quality?
- Which kind of technical challenges have to be considered during the implementation of a serialisation system?
- What are the relevant aspects to be addressed from a quality point of view?
Executive and operational managers of pharmaceutical companies, especially from packaging operations, as well as IT and engineering staff, responsible for the implementation or operation of the new systems are the target group of this event.
Suppliers of packaging and authentication technology and pharmaceutical packaging companies are also welcome.
Draft Delegated Act for the Safety Features – Impact Assessment for the Pharmaceutical Industry
Case Study: Coding and Serialisation at the Manufacturer of Printed Packaging Materials
- Which are the most relevant aspects?
- Consequences for the pharmaceutical industry – What has to be implemented now?
- Outlook – What else can be expected in this context?
Print Quality of Bar and 2D Matrix Codes
- Print and verification of serialized barcodes
- Barcode specification and secure data transmission
- Artwork changes, verification and approval
- Case Studies China, Korea, USA; securPharm/EU
- Case Study QR-China-Barcode for Animal Health
Case Study: Implementation of Serialization and Aggregation – Challenges in Packaging and Supply Chain
- What does the EC Delegated act contain regarding Bar and 2D Codes
- ISO Symbology and print quality standards (Bar- and 2D-Codes)
- What is GS1 Data Matrix, GTIN, NTIN, PPN?
- Testing of codes – why measure a code and not just scan?
- Meaning of measuring results
- China Code
Case Study: Implementation of Serialization – Quality Relevant Aspects
- Areas to be addressed: IT system – carton – processes
- Challenges in the implementation phase
- Equipment qualification/ process validation
- Packaging material management
- Impact on the Supply Chain
FMD and Delegated Regulation on Safety Features - Implementation in Europe and in the securPharm System
- Data Handling – What is relevant, e.g. related to master data, CMOs, packaging, post release?
- In-Process-Control steps – Adaption necessary?
- Transparency and visibility of processes/behaviour – Any consequences?
Serialisation and Coding Requirements Worldwide
- Current status of the implementation in Europe
- State and technical development of the “securPharm World” – news and background information
- Next steps and challenges in 2018
DIN EN 16679 “Tamper Verification Features for Medicinal Product Packaging” – Practical
- Presentation of the different systems in Europe, USA, Russia, South Korea, China, Taiwan, India, Saudi Arabia, Middle East, Egypt, Turkey, Brazil, Argentina etc.
- Collection of country specific requirements – which information is needed?
- Technical specifications for the manufacturing sites
- Worldwide project management
Discussion Forum / Workshops
- Which safety features does the EU-falsified medicines directive require?
- Which tamper verification guidelines / “standards” are available?
- Structure and contents of the European standard EN 16679 / technical characteristics of tamper verification features
- Conclusions / Recommendations for the Practical Implementation
- Qualification and Validation of tamper verification features
Some of the most important topics of this course will be further discussed in Workshops or in interactive discussions.
Implementation of Serialization – Technical Challenges
Participants in this workshop will learn and discuss the following:
- What main topics arise in terms of serialization?
- Challenges and limitations during implementation?
- What challenges do we face due to different print formats?
- Lessons learned
Implementation of Serialization – Quality Relevant Aspects
In this workshop participants will discuss the following topics:
- Serialization and Quality – What is to be considered in general to address quality in the context of serialization?
- Serialization and Packaging Process – Which are the determining factors to maintain quality in course of packaging processes?
- Serialization and Complaints – How should a complaint handling concept look like to address serialization aspects appropriately?
Print Quality of Bar Codes and 2D Matrixcodes
The aim of this workshop is to evaluate how to measure the print quality:
- What is the influence of properties of different print technologies to the code print quality?
- How to evaluate the ISO Data Structures (GS1, PPN, HIBC) used in Bar and 2D Codes?
Participants will be able to attend all these 3 Workshops.