QP Review of More Complex Supply Chains and Applications, EU Member State Differences, Among Issues Facing EMA in Annex 16 Revision

EMA’s GMP/GDP Inspectors Working Group (IWG) is wrestling with how to build into EU GMP Annex 16 the assurance that the Qualified Person (QP) understands the complexities of a globalized supply chain in certifying that a batch complies with GMP/GDP requirements and the new mandates of the Falsified Medicines Directive (FMD).

The working group is also mindful of the challenge the QP faces in understanding what the application commitments are and certifying that they have been met as filings get increasingly complex with the advancing product, process and control technology and the implementation of quality by design.

A third consideration complicating the revision process is the inconsistency in the way different EU member states have been interpreting and applying the existing Annex 16 and the directives it reflects. Areas of difference include where the QP is located vis-à-vis the manufacturing sites, handling of control reports, sampling locations for importation, and the interpretation of certification vs. batch release.

The existing annex on “Certification by a Qualified Person and Batch Release” came into force in 2002. It applies to medicinal products that have EU marketing authorizations or are made in the EU or the European Economic Area for export. The annex is now being refined with the aim of better defining and harmonizing the role of the QP across the member states.

The challenges that the revision of Annex 16 present, and the IWG’s current thinking on how they should be met, were discussed openly by Finnish Medicines Agency Chief Investigator Anne Junttonen at the PDA/EMA conference in Cascais, Portugal in December.

Junttonen, who is serving as the lead on the EMA initiative, framed her remarks with an explanation of how the purpose of companies and the roles of the inspector and qualified person relate to each other.

The purpose of companies by law, she said, is to generate profits for the shareholders. The role of agency inspectors, by contrast, is “to ensure that when companies are doing their legal pursuing of the shareholders profits, they are not causing any risk to the patients.” The qualified person is performing a similar function as the inspector, but has to focus more narrowly on whether the legal requirements are met on a batch-to-batch basis.

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See related IPQ stories:

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

Early Dialogue on Annex 16 Revision Raises Questions About QP/Quality System Relationship