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In letters citing these regulations, FDA notes, “[c]omponent testing is fundamental to drug product quality” and “[w]ithout adequate testing, you do not have scientific evidence that your incoming components conform to appropriate specifications before use in the manufacture of drug products.” 3 Two issues in particular often arose when FDA cited component testing failures: first, where firms failed to perform adequate identity testing of each component lot used in the manufacture of a product and, second, where manufacturers relied on a supplier’s certificate of analysis (COA) without establishing the reliability of the component supplier’s test analyses at appropriate intervals
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