Serialisation & Authentication - Verification of the Authenticity of medicinal products according to Directive 2011/62/EC

14-15 April 2015

Berlin, Germany

Course No 9103

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Speakers

Nils Dickfeld, Meliscout
Maren Göpfert, Boehringer Ingelheim Pharma
Buket Hekiman, PharmaVision
Dr Hiltrud Horn, HORN Pharmaceutical Consulting
Dr Christian Maurer, AbbVie
Konrad Stoeckli, F. Hoffmann-La Roche
Renke Wilken, Managing Director of FFPI

Objectives

It is the conference’s goal to inform about the latest developments in serialisation & authentication coming from the EU directive 2011/62/EC. 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

The European Commission brought into force Directive 2011/62/EC already in 2011.The main goal is the fight against counterfeit medicines. Yet, it took several years - until the mid of 2014 – to define the technical characteristics of the unique identifier delivering the possibility of verification of the authenticity of single folding boxes in the delegated acts. Now, the unique identifier (UI) contains information on the:
Manufacturer product code
Serial Number
National reimbursement number, if present
Batch Number
Expiry Date

The 2D barcode (data matrix) has been set as carrier of the unique identifier, a decision which did not come unexpected but quite late. As the new requirements will become active in 2018, it is high time to start equipping production/packaging lines with the necessary devices.
Several steps are necessary to implement a system compliant with the European requirements:
Installation of a real-time coding, printing & reading (verifying) equipment to packaging lines
Installation of a software system to supply and store completely unique product codes for each folding box
Integration of local systems/databases with a centralised database on a national or European level

Several other countries have also started to run national or international systems. From their experiences can be learnt how to select and how to install the necessary equipment and how to overcome obstacles in the implementation and early operation phases.

The conference will cover the process of implementation and case studies with practical examples will be presented, dealing with questions like:
What are the pre-requisites before starting to equip lines with coding equipment?
What are the requirements of the IT infrastructure, the online-printing and the inspection equipment?
How to implement these systems in a pharmaceutical environment?
What can the IT architecture look like with regard to local and centralised databases?
How have these systems to be qualified and validated?
What has to be considered regarding the packaging material? Printability and regulatory impact of changing the imprint?

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

Fundamentals and Regulatory Requirements

Serialisation & Track and Trace (T&T)
Some history in Pharma-Track and Trace.
Basics: Serialisation of cartons.
Aggregation of cartons, bundles, cases, pallets
EU regulations: the delegated acts
Germany: Securfarm - GS1 initiatives
T&T updated position of the EU community
T&T initiatives worldwide f.i. USA, China, Korea, Brazil etc
Overview of suppliers for hard- and software

Regulatory Aspects for changing the Secondary Packaging (Barcode, Safety features)
Regulatory Challenges for changes of packaging materials (EU/US)
Update on relevant variations guidelines
Strategies for internal & external implementation
Process: Change Control vs. Variations
Affected CTD parts
Timelines
Typical Examples

Technology: Packaging line issues

Pre-requisites for starting line upgrades for serialization
Regulatory requirements
Technical requirements
Material requirements
IT requirements

Printing codes and limitations for printing on folding boxes
A couple of years ago FFPI elaborated a specification for cardboard intended to be used for pharmaceutical boxes. Beside others the specification defined the preconditions that must be fulfilled by cardboard if codes mainly for serialization purposes have to be printed by means of water based ink-jet or laser-ablation in fast running cartoners. Several different cardboard grades are tested since that time on codability. It was found that about 25 % of all grades cannot be coded neither by water based ink-jet nor by laser-ablation. Only about 1 % of all grades are codable with both, water based ink-jet and laser-ablation. UV-curable ink-jet was tested as well. Limiting factor with this process is surface energy of the surface to be coded.
The findings will be presented in detail and the reasons for poor codability will be discussed.

Case Study F. Hoffmann-La Roche
Integration of the new Serialization functionality into existing IT systems
MDMS
EAI
Packaging Line
Barcode readers
Delivery chain network

Best Practice Examples – Case Studies

Case Study F. Hoffmann-La Roche
Qualification and Validation of Serialisation systems
Governance for functional implementation and roll-out
Delivery and cross-system validation
Ownership of Validation deliverables

Case Study Boehringer Ingelheim
Product serialization and authentication – How to implement the new technology?
Necessity of serialization & coding
Our approach
Challenges during implementation
Dos and Don’ts

Case Study AbbVie
Implementation of the serialization concept in the routine operation
Equipment used
Involvement of AbbVie in the SecurPharm Project
Learning from the SecurPharma Project
Special Challenges in the routine operation

Case Study PharmaVision
Five years of experience with serialization and authentication in Turkey
Scope and main characteristics of Track & Trace System in Turkey
Regulatory aspects and timeline for implementation in phases
Case study: Implementation at PharmaVision
Frequently faced problems & Facts as of 2015
Management assessment: Challenges & Proposed solutions

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