January 21, 2025 In 21 CFR 211.ninety four it is stated that “Drug solution containers and closures shall not be reactive, additive, or absorptive to alter the protection, identity, energy, excellent or purity of the drug further than the Formal or proven requirements.” Whilst the code makes this statement, and if expanded on during the relevant FDA Steerage for Market Container Closure Programs for Packaging Human Drugs and Biologics (May possibly 1999), there is absolutely no prescription supplied in the way to execute an extractables and leachables analysis, and that is, certainly, A necessary facet of demonstrating suitability of container closure programs. Study Much more
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