GMP Annex 16 (QP)


Annex 16 of the Guide to Good Manufacturing Practice: Certification by a Qualified Person and Batch release, is the subject of a concept paper by the European Medicines Agency (EMA)

The annex was originally included in the GMP guide in 2002.  The Qualified Person’s (QPs) within the PQG membership will appreciate there has been a tremendous period of change since the content was originally made available; with the number of years that have passed since giving no real indication of the volume of changes in that time.

However, despite the number of changes to legislation, the resulting incremental increases in QP’s responsibilities, and the increasing number of scenarios a QP may face today; the QP’s legal responsibility to patients remains the same.

Therefore the experience of the PQG membership gained from facing the impact of legislative changes and the general evolution of the pharmaceutical industry is incredibly important in making this annex as applicable in practice as it can be.

Some points to consider:

  • The EMA reflection paper on QP discretion.  Can this be clarified in the Annex?
  • With increasing requirements on supply chain assurance and declarations regarding API’s, how will this be incorporated in the text?
  • Scenarios relevant to the industry we operate in (IMPs, generics, virtual companies etc) need to be accounted for rather than the classical model of manufacturers and contractors solely.

To open the concept paper on Annex 16 of the GMP guide (consultation) click HERE

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A final text is expected to be published towards the end of 2014 with a six month implementation period.