Track & Trace Training Course

Track & Trace Training Course

Heidelberg, Germany

Course No 15479


Costs

This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Thomas Brückner, BPI (German Pharmaceutical Industry Association), Berlin, Germany
Maren Göpfert, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany
Horst Kastrup, Vitapharma Generics, Bad Homburg, Germany

Objectives

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 just 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.

Background

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.

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?

Target Group

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.

Programme

Draft Delegated Act for the Safety Features – Impact

  • Assessment for the Pharmaceutical Industry
  • 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?
Case Study: Coding / Serialisation / Artwork at the Manufacturer of Printed Packaging Materials
  • Print and verification of serialized barcodes
  • Barcode specification and secure data transmission
  • Artwork changes, verification and approval
  • Case Study China Barcode & DMX Helper Code
  • Case Study QR China Barcode for Animal Health
Print Quality of Bar and 2D Matrix Codes
  • 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 – Technical Challenges
  • Areas to be addressed: IT system – carton – processes
  • Data management
  • Equipment related aspects
  • Packaging material management
Case Study: Implementation of Serialization – Quality Relevant Aspects
  • How to set up and start a packaging line with serialization
  • Challenges in the implementation phase
  • Equipment qualification/ process validation
  • Quality related aspects e.g. adaptation of IPCs, training, SOPs etc
The Delegated Regulation on Safety Features has just arrived - Consequences for
  • Companies. Requirements to join securPharm
  • Short overview – what is the Delegated Regulation about?
  • Timelines of legislation and stakeholder-driven systems
  • How can the ability to deliver pharmaceutical products be ensured after 2019?
Serialisation and Coding Requirements Worldwide
  • Presentation of the different systems in Europe, Brazil, Turkey, China, USA, South Korea, Saudi Arabia, etc.
  • Collection of country specific requirements – which information is needed?
  • Technical specifications for the manufacturing sites
  • Worldwide project management
DIN EN 16679 “Tamper Verification Features for Medicinal Product Packaging” – Practical Implementation
  • Which safety features does the EU-falsified medicines directive require?
  • Which tamper verification guidelines / “standards” are available?
  • Confirmation of DIN EN 16679 by the EU Commission
  • Structure and contents of the European standard EN 16679 / technical characteristics of tamper verification features
  • Conclusions / Recommendations for the Practical Implementation

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