Tablets & Capsules


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10 October 2019 Tablets & Capsules John Giannone, Michael Rashed, Peter Claise, and Doug Podolsky USP I FDA warning letters cite drug manufacturers for failing to test excipients or verify COAs regulatory compliance This article discusses the recent increase in FDA warning letters citing cGMP violations related to excipients and describes USP's analysis of the excipient-related warning letters issued from 2013 through 2018. It also explains how USP's pro- grams and resources can help drug companies comply with FDA regulations. n 2017 and 2018, the FDA's Center for Drug Evalua- tion and Research (CDER) issued 38 warning letters to pharmaceutical firms in the US and 12 other countries for failing to test for identity of incoming excipients, failing to verify the information on excipient suppliers' certificates of analysis (COAs) at regular intervals, or both. This compares with three warning letters in the four years from 2013 to 2016 that specifically cited excip- ients or inactive ingredients, according to an analysis by the US Pharmacopeia (USP) of FDA warning letters

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