January 21, 2025 In 21 CFR 211.ninety four it really is stated that “Drug item containers and closures shall not be reactive, additive, or absorptive to change the protection, identification, power, quality or purity of your drug further than the Formal or set up necessities.” When the code tends to make this statement, and when expanded on while in the associated FDA Assistance for Market Container Closure Devices for Packaging Human Medicine and Biologics (May perhaps 1999), there is absolutely no prescription available in how you can execute an extractables and leachables analysis, that is, certainly, A necessary element of demonstrating suitability of container closure techniques. Browse More
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