Revision of Annex 16: Results of Public Consultation
Recommendation
29/30 April 2025
Hamburg, Germany
Batch Manufacturing Documents: from Preparation to Operational Excellence
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The responses to the public consultation on the revision of Annex 16 (Certification by a Qualified Person and Batch Release) have been published.
Amongst other Organisations like the Austrian QP Association, the European QP Association (EQPA) also gave feedback to the draft annex 16. 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.
The responses can be found on the European Commission website.
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