January 21, 2025 In 21 CFR 211.ninety four it's said that “Drug products containers and closures shall not be reactive, additive, or absorptive to change the protection, identity, strength, top quality or purity on the drug over and above the Formal or proven needs.” Whilst the code makes this assertion, and if expanded on during the related FDA Assistance for Business Container Closure Techniques for Packaging Human Medicine and Biologics (May perhaps 1999), there is absolutely no prescription offered in how to execute an extractables and leachables analysis, which happens to be, not surprisingly, an essential element of demonstrating suitability of container closure systems. Read through Additional
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December 19, 2024 This is part 3 of A 3-section collection regarding how recent updates to ICH Q2 and Q14 is often applied to the event and validation of leachables solutions.
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