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32B July 2020 Tablets & Capsules T How to perform an out-of-specification investigation Tara Lin Couch EAS Consulting Group quality This article details how to perform an out-of-specification investigation for dietary supplement products. he establishment of specifications for raw materials, in-process materials, and finished products is one of the essential regulatory requirements of current good man- ufacturing practices (cGMPs) for dietary supplements as established by the FDA [1-3]. These specifications define material and product quality. To ensure that the neces- sary characteristics—identity, purity, strength, composi- tion, and limits of contaminants—are present, companies must perform thorough material and product testing. Testing can be conducted either by the manufactur- er's in-house laboratory or by a contract laboratory. In either case, the results will determine whether or not the company can release the material for use and dis- tribute the product. When a test result falls outside of the acceptance criteria for a specified characteristic, the material is considered "out of specification" (OOS). All OOS results must be investigated in accordance to the cGMPs, and quality control personnel must conduct a material review and make a disposition decision [4]. OOS investigation The purpose of an OOS investigation is to determine the cause of the OOS result during testing or manufac-

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