January 21, 2025 In 21 CFR 211.ninety four it is stated that “Drug merchandise containers and closures shall not be reactive, additive, or absorptive to change the safety, identity, strength, good quality or purity from the drug past the Formal or recognized needs.” Although the code makes this statement, and if expanded on inside the similar FDA Advice for Industry Container Closure Methods for Packaging Human Medication and Biologics (May well 1999), there isn't any prescription supplied in the way to execute an extractables and leachables evaluation, that's, certainly, A vital aspect of demonstrating suitability of container closure methods. Read through Additional
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