EMA and PIC/s Issue Concept Paper for GMP Annex 11 (Computer Systems)

A 5-page concept paper was issued by the European Medicines Association (EMA) and Pharmaceutical Inspection Co-operation Scheme (PIC/s) on 16th November 2022 with a deadline for comments by 16th January 2023.

The paper identifies a number of proposed updates to reflect the significant advancements since Annex 11 was issued back in 2011 and includes guidelines for the acceptance of artificial intelligence / machine learning algorithms used in critical GMP applications.

The EMA GMP/GDP Inspectors Working Group and the PIC/S Sub-committee on GMDP Harmonisation have jointly recommended that the current version of Annex 11, Computerised Systems, be revised accordingly.

The proposed timelines indicate an updated Annex 11 being issued for a 3-month consultation in December 2024 and a final version being published in June 2026.

JensonR+ will be taking the opportunity to review the concept paper and provide comments by 16th January 2023 and strongly recommend other interested parties do the same for this important area of GxP.

Mark King
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