Summary of Anticipated Changes to Annex 1
January 11, 2017
EU GMP Annex 1 on sterile product manufacturing is undergoing a major revision, which is being conducted jointly with PIC/S. This is a total re-write of this critical Annex. Whilst we have not had a formal draft published yet, we do now have a very good idea of the changes that will be in the draft when it is published, and of the areas of contention that are still being debated. This fish-bone diagram will provide you with the latest news regarding the revision of Annex 1, which will help sterile product producers prepare for the major changes that are coming.
How NSF Can Help You
Get in touch to find out how we can help you and your business thrive.
What’s New with NSF
iNADO Partners with NSF to Support Members and Athletes
May 27, 2026iNADO is pleased to welcome NSF’s expertise and experience in support of its members and the athletes they serve
NSF Ends UK’s Three-Year Testing Gap with REG 31 Testing Designation
May 20, 2026NSF’s Oakdale laboratory becomes the UK’s sole facility offering comprehensive BS 6920 and REG 31 testing, closing a critical drinking water safety gap.
NSF Annual Review and Impact Report 2025 Now Live
April 20, 2026NSF has published its Annual Review and Impact Report 2025, detailing the organization’s progress over the past year and outlining strategic priorities for 2026.
Visit NSF at Making Pharma 2026
April 10, 2026Connect with our experts to discover how we help leading pharmaceutical and biotechnology companies achieve regulatory compliance and operational excellence.