JUST IN

EU GMP UPDATES  released July 07, 2025

The IT trilogy:

• Annex 11 Computerised Systems draft revision
• Annex 22 Artificial Intelligence – new GMP Annex
• Chapter 4 Documentation draft revision to include Data Governance / Data Integrity and more

All to be covered in GMP Updates by Karen Taylor on 22 July, 2025 together with ICH Q1 Stability Guidance overhauled to a 108 page document

and

UK’s MHRA. New regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect 23 July 2025!

And much more

Don’t get left behind!

Some new guidances which will be addressed in the GMP refresher:

• FDA draft guidance: Use of Artificial Intelligence to Support Regulatory Decision-Making (January 2025)
• EMA Reflection Paper: Use of AI in the Medicinal Product Lifecycle
• April 2025: ICH Q1 Step 2 draft: Stability Guidelines for Drug Substance and Drug Products released.
  The draft is 108 pages and provides detailed recommendations for all aspects of stability testing.
  This guidance will affect every pharmaceutical company in the world!
• January 2025: FDA draft Guidance for Industry: Considerations in complying with 21CFR part 211.110 In-process Sampling and Testing.
  Any company manufacturing for the USA / CMOs should be aware of!
• UK’s MHRA: New regulations for decentralised manufacture, including point of care and modular manufacture, which come into effect 23 July 2025!

and FDA has stated they will perform unannounced inspections outside of the USA, so where we previously expected upfront coordination, we could soon see FDA inspectors turning up on the doorstep!

Inspection ready at all time is therefore needed.

Third party audit and QP responsibilities continue to be problematic both for Israeli MOH and for EU and FDA. Additional guidance and expectations have been provided recently.

All of the above and a lot more in the updates in July.

This Refresher will meet your requirement for annual GMP training!

ON THE MENU-25264

• Hot topics:
  • Recent inspection findings
  • Review and discuss US FDA 483 and warning letter findings
• Updates to:
  • EU GMPs and annexes, guidelines
  • US GMPs and guidances
  • ICH
  • PIC/s
  • WHO
  • Pharmacopeias
• Want to know what’s happening in the pharmaceutical industry?
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• Has your QMS health improved since 2023 – benchmark with colleagues and Karen and decide.