EU Moves to Revise its GMP Annex 16 to Clarify QP Role

The EMA’s GMP/GDP Inspector’s Working Group (IWG) is working on a concept paper for revising EU GMP Annex 16 with the aim of better defining and harmonizing the role of the QP across the EU member states.

The IWG is reevaluating how the responsibilities of the QP should be defined in the context of a more quality system-oriented mindset and the increased complexity of the batch release process resulting from technological advances and increasingly intricate supply chains.  Also at issue are differing EU member state interpretations of the Annex 16 requirements.

The existing annex on “Certification by a Qualified Person and Batch Release” came into force in 2002.  It provides guidance for QPs on batch certification of medicinal products that have EU marketing authorizations or are made in the EU or the European Economic Area for export.

At the PDA/EMA conference in early May, Finnish National Agency for Medicines (FIMEA) Senior Pharmaceutical Inspector Anne Junttonen, who is the IWG lead on the Annex 16 review, provided a preview of the concept paper now under development.

This revision “concerns us all,” Junttonen emphasized, urging all stakeholders to participate in the revision and comment process. In addition to quality assurance department personnel and inspectors, she urged that process development personnel and assessors “get involved” with the Annex 16 revision.

[More on the issues prompting the revision of Annex 16 provided for subscribers here.  See IPQ “In the News” July 7 companion story on the early industry/regulator dialogue and industry input on changes it would like to see in the revision.  Nonsubscribers can purchase both stories for $195 by contacting Jonathan Trethowan (  For subscription/license information, click here.]