January 21, 2025 In 21 CFR 211.94 it is said that “Drug item containers and closures shall not be reactive, additive, or absorptive to alter the protection, identity, power, quality or purity in the drug outside of the official or recognized demands.” Though the code would make this assertion, and when expanded on in the linked FDA Steerage for Field Container Closure Methods for Packaging Human Drugs and Biologics (May possibly 1999), there's no prescription available in ways to execute an extractables and leachables evaluation, which can be, needless to say, an essential aspect of demonstrating suitability of container closure systems. Read A lot more

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December 19, 2024 This is part 3 of a three-element sequence about how recent updates to ICH Q2 and Q14 could be applied to the event and validation of leachables solutions.

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