Revised Annex 16: Comments of the European QP Association

Recommendation

29/30 March 2023

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In July this year, the European Commission has published the draft of the new EU-GMP Guideline Annex 16 "Certification by a Qualified Person and Batch Release". Stakeholders were invited to comment on this draft.

As the major interest group of Qualified Persons in Europe, the European QP Association (EQPA) has provided a comprehensive summary as feedback to the proposal. This was developed by an expert group of the association, also based on the feedback given by individual members in a survey initiated by the EQPA.

The EQPA highly appreciates the on-going revision of Annex 16 to the EU GMP Guide, reflecting the current changes in the pharmaceutical environment, including the globalisation of supply chains as well as new quality control strategies. The Association also welcomes the further steps to harmonization of requirements in the Member States, by clarifying which have to be performed by a Qualified Person (QP) personally and those that can be delegated. This includes the reliance on company or site - based quality systems, as described in Chapter 1 of the EU GMP Guide part I. The  EQPA also expressed  some concerns regarding the implementation in practice for some provisions and made some proposals reading terminology.

Before official publication by the EU, the comments can be seen in the members' areas of the websites of the European QP Association and the European Compliance Academy.