January 21, 2025 In 21 CFR 211.ninety four it really is said that “Drug product or service containers and closures shall not be reactive, additive, or absorptive to alter the security, id, toughness, quality or purity on the drug over and above the Formal or founded necessities.” Whilst the code would make this statement, and when expanded on within the associated FDA Direction for Sector Container Closure Methods for Packaging Human Medicine and Biologics (Might 1999), there isn't a prescription available in the best way to execute an extractables and leachables analysis, which is, of course, A vital facet of demonstrating suitability of container closure systems. Read Additional
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December 19, 2024 This is part three of A 3-section series regarding how modern updates to ICH Q2 and Q14 is often placed on the event and validation of leachables approaches.
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