GMP News - Quality Assurance

The first version of the "Sharing Drug Substance M7 information to HA and MAH: "How to do" document -Interpretation of the ICH M7 guideline and other relevant guidelines with regard to M7 data sharing" and the associated templates were finalised in March and April 2023 and are now available on the APIC website.

Since the beginning of May 2023, the chapter <2> Oral "Drug Products - Product Quality Tests", which is part of the heading "General Tests & Assays", has been published for comments on the website of the Pharmacopeial Forum of the USP. Comments and remarks on this draft, which is based on the previous version from August 2020, can be submitted until 31 July 2023.

The US FDA recently published a discussion paper addressing artificial intelligence in the manufacturing of medicinal products. The FDA is considering the extent to which its risk-based regulation is applicable to AI technologies in the manufacturing of medicinal products.

EMA has published a new version of the "3-year work plan for the Quality domain". This also includes partly renewed timeframes for the revision of GMP specifications.

The CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) updated the Q&A document on "Renewals" in March 2023 and published it on the HMA (Heads of Medicines Agencies) website in the CMDh - Questions & Answers section in April.

Swissmedic has specified the conditions for the submission of an audit report by the Responsible Person as proof of GMP compliance of foreign manufacturers.