January 21, 2025 In 21 CFR 211.94 it is actually mentioned that “Drug merchandise containers and closures shall not be reactive, additive, or absorptive to alter the protection, id, strength, excellent or purity of the drug further than the official or founded necessities.” Whilst the code would make this assertion, and when expanded on during the linked FDA Guidance for Field Container Closure Methods for Packaging Human Medication and Biologics (May possibly 1999), there is no prescription offered in tips on how to execute an extractables and leachables analysis, which can be, of course, A vital element of demonstrating suitability of container closure programs. Read A lot more
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