August 21, 2025 - EU GMP Annex 1 - Consulting and Examinations
Aug 21, 2025 - Cosmetics
August 21, 2025 - EU GMP Annex 1 - Consulting and Examinations
A common topic during regulatory inspections in pharmaceutical manufacturing facilities is the handling of OOS situations (Out Of Specification). There is an increasing emphasis on root cause analysis (Root Cause Analysis, RCA). In Chapter 1 (Pharmaceutical Quality System) of the EU GMP guidelines (Annex I) it states, among other things:
1.4 (xiv): "An appropriate root cause analysis should be performed when investigating deviations, suspected product defects, and other problems."
The RCA should urgently be linked with the operational CAPA system (Corrective and Preventive Action). Furthermore, it is observed in operational practice that references to human errors are increasingly less accepted.
We comprehensively examine the microbiological quality of your pharmaceuticals for you. Beyond the examinations, we are also happy to advise you on the occurrence of OOS results and targeted root cause analyses (RCA).
For questions, our customer consultants are very happy to assist you.
Sources:
- www.bav-institut.de
- www.gmp-navigator.com