Issue link: https://www.e-digitaleditions.com/i/1173734
12 October 2019 Tablets & Capsules that drug products are made in accordance with the cGMP requirements for safety, identity, strength, quality, and purity. The FDA has issued a guidance on contract manufacturing and quality agreements [3]. cGMP consultants. In 36 of the 38 excipient-related warning letters from 2017–2018 that USP analyzed, the FDA strongly recommended that companies engage a qualified consultant to assist their firm in meeting cGMP requirements. In one of the remaining cases, the FDA acknowledged that the company had already hired a cGMP consultant. USP standards and resources USP's science-based public standards and resources can help with drug component testing and supplier COA validation. For example, USP monographs and quality standards for excipients provide the appropriate, validated test procedures to establish the identity, purity, and limits of contaminants in an excipient. Currently, the United States Pharmacopeia and the National Formulary (USP– NF) includes more than 530 excipient monographs. In addition, USP is continually developing new monographs and public standards for materials that are not currently contained in USP–NF. USP also maintains extensively characterized physical reference standards that help pharmaceutical manufac- humans worldwide. Both the FDA and industry have tried to educate manufacturers to help ensure that they are using quality materials. USP has updated the glyc- erin monograph to include this adulterant as part of the required identification test, and the FDA issued a guid- ance on the testing of glycerin for DEG [2]. Five firms cited in 2017–2018 FDA warning letters that failed to follow USP's established testing procedure for DEG contamination in glycerin raw material from their suppliers were instructed to provide a detailed risk assess- ment for their drug products containing glycerin that were within expiry in the US market. If the firms found that they had released any batch for which results were out of specification, they were instructed to indicate the corrective actions they would take, such as customer notifications and product recalls. One additional firm had already initiated a recall of all their drug products from the US market because of cGMP violations, includ- ing failure to test for DEG contamination in glycerin, prior to being issued an FDA warning letter. Contract manufacturers. Several of the warning let- ters in 2017–2018 notified drug manufacturers that, as contract facilities, they are responsible for the quality of the drug products they produce regardless of the quality agreements they may have with their suppliers or prod- uct owners. In other words, they are required to ensure