January 21, 2025 In 21 CFR 211.94 it can be said that “Drug products containers and closures shall not be reactive, additive, or absorptive to change the protection, identification, energy, good quality or purity in the drug outside of the Formal or set up requirements.” While the code would make this statement, and when expanded on while in the similar FDA Direction for Sector Container Closure Devices for Packaging Human Drugs and Biologics (May perhaps 1999), there is not any prescription presented in ways to execute an extractables and leachables analysis, that is, naturally, an essential aspect of demonstrating suitability of container closure programs. Read Far more
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