EU GMP guide Annex 16 revision

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In the world of QPs, Annex 16 is the Annex that many QPs fall asleep thinking about.  For many QPs it provides the framework for how we operate, for others it is a useful tool to explain what a QP is in the global companies we work in.

However it is used, Annex 16 provides a framework for one of the most challenging and necessary roles in our industry.  Whilst advancements in all areas result in more and more innovative medicines, the one constant is the need for medicines to be assessed to be safe and efficacious before being released into the EU.  The QP has an important role in ensuring this happens.

If the QPs in the PQG want to ensure that this document reflects their experience then this is your opportunity.  I would strongly urge that you provide your insight and experience to allow the PQG to continue to influence topics that affect our daily work.

Some points of interest:

  • Many will note that the ‘routine’ duties have been replaced by a large number of operational duties.  How does delegation work in practice for you?
  • The 2009 ‘Reflection paper’ on ‘QP discretion’ has been incorporated.  How will you ensure the QMS is adapted appropriately?  Is your Quality Risk Management system robust and appropriately understood to enable these challenging decisions to be made?
  • Real Time Release Testing has been incorporated to reflect relatively recent developments in the industry with regard to batch release.

How can you help your fellow members?

  • Quite simply the PQG has historically had a great deal of influence in this area with some PQG members being instrumental in the drafting of previous iterations.  We hope to continue this influence.

To open the consultation on the revised chapter, please click HERE

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Please make it clear which part of the text you are referring to (i.e. chapter heading) and provide as much information as possible to add maximum value.

When should you comment by?

Please submit comments by the 18th October 2013.