January 21, 2025 In 21 CFR 211.ninety four it truly is stated that “Drug product or service containers and closures shall not be reactive, additive, or absorptive to alter the protection, identity, strength, good quality or purity from the drug over and above the Formal or established needs.” Even though the code will make this assertion, and if expanded on in the associated FDA Assistance for Field Container Closure Units for Packaging Human Drugs and Biologics (May possibly 1999), there is no prescription provided in tips on how to execute an extractables and leachables analysis, which is, not surprisingly, A necessary element of demonstrating suitability of container closure devices. Read through Far more

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