Component Testing Gains Prominence in Drug Product GMP Warning Letters as FDA Focus Intensifies on OTC Topicals and Upstream Supply Chain

Inadequate testing of incoming components is a leading problem area being cited by FDA on finished drug product GMP warning letters and is particularly prevalent in the expanding number of those addressing compliance at topical manufacturers worldwide.

FDA is expressing concern that each component is not being tested by the dosage manufacturer for conformity with all of its specifications and/or that specific identification tests are not being conducted on components that have been accepted based on the supplier’s certificate of analysis (CoA), as required by CFR 211.84.

IPQ’s analysis of drug product GMP warning letters issued from 2012 through the first quarter of 2014 shows that over one in three of those addressing finished product manufacturing (20 of 57) have highlighted the facility’s non-compliance with 211.84. Among warning letters addressing topical manufacturing, the percentage soars to three in four (16 of 21).

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