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9 November 2011

New Concept Paper on Annex 16 of the EU-GMP Guide

The European Medicines Agency (EMA) has published a Concept paper on revising Annex 16 of the Guide to Good Manufacturing Practice: Certification by a Qualified Person and Batch Release.

The respective annex was introduced in 2002 giving guidance on the certification and batch release of medicinal products within the European Union (EU) and European Economic Area (EEC). The intention was to give guidance on questions regarding the minimum personal effort for a Qualified Person (QP) when certifying a batch, the prerequisites for relying on statements from other QPs and what to do when certifying batches manufactured by third parties in third countries.

Since that time, the pharmaceutical environment has been changing and new technologies like, for example, PAT and Real Time Release Testing have been developed. And the implementation of ICH Q8, Q9 and Q10 is having a huge impact on pharmaceutical quality management systems. Additionally there is a lack of harmonisation in the requirements between various Member States. Therefore, EMA proposes "that an overall revision of Annex 16 of the GMP Guide is undertaken to bring it up-to-date with new legislation, with the positive and negative trends seen in the medicines business environment and with the developments in science and technology. A revision will also serve to harmonise the interpretation of existing legislation and GMP guidance between the Member States" and it is recommended that "the expectations on the QPs personal involvement and knowledge of the products and production sites should be strengthened."

According to the Concept Paper, the aim of the revising process is:

  • to determine clearly and unambiguously the prerequisites for certification and release of a batch of medicinal product

  • to minimise misinterpretation

  • to clarify the extent of personal involvement of the QP versus reliance on quality systems and other personnel

  • to harmonise interpretations across Member States regarding when and where samples should be taken

  • to provide guidance on what is understood by certification of compliance with the Marketing Authorisation with respect to the Reflection Paper published by EMA on the QP's discretion when dealing with minor deviations from the details described in the Marketing Authorisation

  • to explore implications of new legislation related to active pharmaceutical ingredients (APIs), excipients and

  • to ensure that the guideline is up-to-date concerning investigational medicinal products (IMPs

There are a number of additional areas where clarifying guidance regarding the QP is strongly desired, e.g.:

  • The QP's position in an organisation's structure

  • The physical location of the QP

  • Independence of the QP from the Head of Production Manager and/or Quality Control

  • The QP's role in product defects and related investigations

End of consultation (deadline for comments) will be 31 January 2012. On November 23rd, there is an Interested Parties Meeting with EMA's GMDP Working Group in London on the revision of Annex 16. The European QP Association will be actively involved in the upcoming discussion. Therefore the European QP Association will provide a presentation at the next Interest Parties Meeting with EMA. The outcome of the Interested Parties Meeting will be presented at the QP Forum in Budapest from 1-2 December .

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