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Annex 16: QP Certification and Batch Release

Friday the 11th November 2011

On the 28 October the EMA GMDP Inspectors Working Group (GMP/GDP IWG) published a Concept Paper on revising Annex 16. Anne Junttonen, a Senior Pharmaceutical Inspector with the Finnish National Agency for Medicines (FIMEA) and who serves on the EMA GDP/GMP IWG, is the leader of the group’s effort to revise this Annex. The Concept Paper states that “new legislation and developments in science and technology have created new areas where further guidance is desired; both by the regulators and the industry”.

This Concept Paper recognises that there is currently a lack of harmonisation in requirements between Member States. It lists several areas that are currently being interpreted differently across the EU:-

  • What is the minimum a Qualified Person (QP) must personally carry out when certifying a batch?
  • What are the prerequisites for relying on statements from persons other than fellow QPs?
  • How is the Control Strategy and the batch certification release process linked?
  • What are the expectations for QPs reviewing batch records manufactured by third parties in third countries?
  • What knowledge should a QP have about the site(s) involved in the manufacturing of a batch?
  • What actions are expected from the QP when a batch cannot be certified and therefore released?
  • Sampling and testing of batches produced outside the EU/EEA.
  • Dealing with minor deviations from marketing authorisations.

The Concept Paper states “The implications of the new legislation related to active pharmaceutical ingredients (APIs), excipients and finished product to the batch certification and release procedures should be explored, as well as ensuring that the guideline is up-to date concerning investigational medicinal products.”

The most contentious area that has to be addressed by the revision of Annex 16 is the QP’s discretion when dealing with minor deviations from the details described in the Marketing Authorisation, which was addressed in the Reflection Paper published by EMA in 2007 and updated in 2009. The concept paper states “This reflection paper has been misinterpreted in some cases and there are many questions regarding its status. Annex 16 would be an appropriate place to provide guidance on what is understood by certification of compliance with the Marketing Authorisation.” It will be very interesting to see the wording that addresses this issue in the draft revision that should be published in mid-2012.

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

The concept paper states that as these questions are, not directly related to the batch certification activity itself, they are not in the scope of the current Annex 16. They could be addressed in future revisions of applicable Chapters of the GMP Guide or in the Q&A’s section on EMA’s website.

The Concept Paper ends with the following timetable to lead to the revision of Annex 16:-

  • Release of Concept Paper for Public Consultation: October 2011
  • Deadline for comments on Concept Paper: January 2012
  • First draft of revised Annex 16 for discussion in IWG: May 2012
  • Agreement of Annex 16 draft guidance in IWG: October 2012
  • Release of Annex 16 draft guidance for Public Consultation: December 2012
  • Interested Parties meeting: February 2013
  • Deadline for comments on Annex 16 draft guidance: End February 2013
  • Final draft of revised Annex 16 for discussion in GMP/GDP IWG: September 2013
  • Adoption of revised Annex 16 guidance by European Commission November 2013

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