Analytics issues appear in the majority of FDA warning letter citations for manufacturing, including unvalidated methods and inadequate procedures for responding to out-of-spec test results. The European Compliance Academy reported the findings after reviewing warning letters issued to 14 makers of drug ingredients.
The academy noted 2011 saw a nearly three times rise in the number of warning letters issued to such manufacturers. Companies in the U.S. and China led in terms of warnings with four each. India garnered three while China, Spain and the U.K. each earned one apiece.
The academy's analysis showed that manufacturer location had no bearing on the prevalence of analytics shortcomings. Another finding: They were prominent in 2010 warnings, as well.
Among specific issues the academy found were misinterpretation of analytical data, inadequate documentation, and failure to investigate out-of-spec findings.
Failure to conduct stability tests, missing analytical raw data, and lack of SOPs are among common citations.
- here's the report
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