January 21, 2025 In 21 CFR 211.94 it's mentioned that “Drug products containers and closures shall not be reactive, additive, or absorptive to change the security, id, strength, quality or purity in the drug over and above the Formal or set up needs.” While the code makes this statement, and when expanded on during the relevant FDA Steerage for Sector Container Closure Methods for Packaging Human Medications and Biologics (May well 1999), there isn't any prescription made available in the way to execute an extractables and leachables evaluation, which is, needless to say, A vital element of demonstrating suitability of container closure systems. Read through More
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