Contractor audit failings jump into MHRA top 10 deficiencies
Shortcomings in audits of suppliers and contracts was the sixth most common failing, up from 11th a year ago, noted by UK Medicines and Healthcare products Regulatory Agency (MHRA) inspectors in fiscal 2011.
In its review of GMP (good manufacturing practice) failings in 2011 the MHRA gives examples of audit deficiencies, including: “Audit reports performed were to a predefined general generic checklist, there was no data to support the audit except ticks on the checklist.”
This is one of 50 observations MHRA inspectors made about supplier and contractor audits in the last fiscal year. Over this period audit failings accounted for seven per cent of all deficiencies, up year-on-year by one percentage point.
Increased audit observations coincided with a dip in deficiencies inspectors identified in technical agreements between manufacturers and their suppliers and contractors. The number of technical agreement observations made by the MHRA dropped by more than 40 per cent year-on-year.
Adding the 28 observations about technical agreements to the 50 about audits makes deficiencies tied to supplier and contractor oversight the second most common failing identified by the MHRA. The 78 observations only trail the investigation of anomalies, which was noted 97 times last year.
FDA actions
In fiscal 2011 the US Food and Drug Administration (FDA) also took action against companies that failed to properly oversee contractors. Last June the FDA hit FSC Laboratories with a warning letter for lacking a quality agreement with its contract manufacturer and Genentech was also targeted.
A September 483 sent to the big biotech noted multiple failings in its relationships with contractors. FDA inspectors were critical of data to support work done by a contract laboratory. Genentech also lacked evidence its manufacturer of Avastin vial caps minimised risk of adulteration, the FDA wrote.
