Recently, the UK MHRA published a review of the main GMP deficiencies for the period from April 2011 to March 2012. They performed 303 relevant inspections with 26 critical observations and 644 major observations.
The Top 10 Deficiency Categories of these inspections are:
- Investigation of Anomalies
- Quality Management - Change Control
- Investigation of Anomalies - CAPA
- Complaints and Product Recall
- Quality Management
- Supplier and Contractor Audit
- Contamination, Chemical/Physical - Potential For
- Documentation-PSF/Procedures/Technical Agreements
- Documentation - Manufacturing
- Process Validation
As an example, the number one deficiency "Investigation of anomalies" was documented in 97 cases, "Change Control" in 70 cases and "CAPA" in 63 cases.
Classical reasons of deficiencies are also found in many cases, e.g. the field of personnel training and hygiene are still represented with 57 cases or the investigation of OOS in 33 cases. Direct contaminations of product were found 75 times, 44 of which were chemically/physically based and 31 microbial. This implicates, that "Contamination" is for the first time one of the "Top Ten".
For further details please see the presentation "Deficiency Data Review - April 2011 to March 2012".
Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)