PIC/S takes over new Annex 15 on Validation/Qualification
Recommendation
Thursday, 12 February 2026 9 .00 - 17.00 h
Best Practice for Manual and Automated Visual Inspection of Parenterals
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
Mid of April the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has taken over the revised Annex 15 of the EU GMP Guide on Validation and Qualification in their GMP Guide. We reported about the Annex 15 revision in detail. The Annex 15 takeover by PIC/S was expected, but is yet interesting as now the new requirements with regard to validation and qualification will also be applicable in non-EU countries - for instance in Canada, Australia, Taiwan and Argentina.
Similar to the EU Annex 15 the document becomes effective on 1 October 2015.
Please see the PIC/S website for the Guide to Good Manufacturing Practice for Medicinal Products - Annex 15.
Related GMP News
10.12.2025VDI 6022 Sheet 8.1 published: Qualification for the cleaning of air-conditioning systems
10.12.2025Typical GMP Deficiencies in the Area of Technology in FDA Inspections 2024/2025
03.12.2025Deficient Water System: Warning Letter from the FDA
26.11.2025Revised Container-/Closure-Integrity Testing (CCIT) Position Paper available
12.11.2025New VDI Guideline 2083 Sheet 22 published: Measurement of Condensable Airborne Substances