January 21, 2025 In 21 CFR 211.94 it truly is stated that “Drug product containers and closures shall not be reactive, additive, or absorptive to alter the security, identity, energy, top quality or purity in the drug over and above the official or founded prerequisites.” While the code tends to make this statement, and when expanded on during the relevant FDA Guidance for Market Container Closure Programs for Packaging Human Medicines and Biologics (May perhaps 1999), there is not any prescription supplied in ways to execute an extractables and leachables analysis, which is, certainly, A vital facet of demonstrating suitability of container closure devices. Browse More
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