Insufficient failure investigations, supplier qualification, stability testing – the most common GMP violations in the FDA warning letters

New Drug Approvals

An analysis of warning letters issued in the past fiscal year essentially shows the same pattern of frequently cited GMP violations. It also shows a noticeable increase in the GMP deficiencies relating to the qualification of suppliers and their certificates of analysis. Find out more

http://www.gmp-compliance.org/enews_4390_Insufficient%20failure%20investigations%2C%20supplier%20qualification%2C%20stability%20testing%20-%20the%20most%20common%20GMP%20violations%20in%20the%20FDA%20warning%20letters_8500,8489,S-QSB_n.html

The analysis of the warning letters issued in the last fiscal year shows no surprise at a first glance: as in recent years the FDA detected an insufficient investigation of unexplained discrepancies and deviations from defined standards and specifications in their inspections. The corresponding paragraph 21 CFR 211.192 requires that the drug maker clarifies the reason for the deviation, takes corrective actions and also creates a complete documentation. In the last 5-year period on average annually about 22 companies received a warning letter listing this GMP deficiency. This fact shows that many quality assurance departments’ understanding of deviations handling, failure investigations and corrective actions is frequently fragmentary.

Quite interesting…

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