News

MHRA Report Discusses Top GMP Deficiencies from April 2011 - March 2012

08/23/12

The MHRA just published a report detailing 303 investigations between April 2011 - March 2012. They found the top 10 GMP deficiencies to be:

1. Investigation of Anomalies (97 cases)
2. Quality Management –Change Control (63)
3. Investigation of Anomalies –CAPA (59)
4. Complaints and Product Recall (58)
5. Quality Management 6Supplier and Contractor Audit (50)
6. Contamination, Chemical/Physical –Potential For (44)
7. Documentation-PSF/Procedures/Technical Agreements (39)
8. Documentation –Manufacturing (35)
9. Process Validation (34)

View the full report.