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

Key issues for industry as the EU moves to revise Annex 16 will include how much responsibility can reasonably be placed on the QP, how those responsibilities dovetail with the quality system and its management, and the definition of the term “personal knowledge” as used in the current version of the annex and its relationship to auditing.

These issues were among those surfacing at an informal meeting between some of the key industry stakeholders and top EU regulators, held immediately following the PDA/EMA conference in London in May.

The discussion session occurred the day after a presentation at the conference on the Annex 16 revision drivers by Finnish National Agency for Medicines (FIMEA) Senior Pharmaceutical Inspector Anne Junttonen, who serves on the EMA GDP/GMP Inspectors Working Group (IWG) and has the lead on the group’s effort to revise the annex (IPQ “In the News” July 7).

In her presentation at the conference, Junttonen had stressed the IWG’s interest in having industry/regulator dialogue early in the revision process to help the group in its consideration of how the role of the QP should be redefined in view of the QbD regulatory framework and an increasingly complex manufacturing/supply chain.  The session the following day provided the initial opportunity for this dialogue to take place.

[More on the industry/regulator dialogue that took place at the discussion session is provided for subscribers here.  Nonsubscribers can purchase both this and the companion story on Junttonen’s presentation for $195 by contacting Karen Bertani (Jonathan@ipq.org).  For subscription/license information, click here.]