January 21, 2025 In 21 CFR 211.94 it can be stated that “Drug product containers and closures shall not be reactive, additive, or absorptive to change the security, identity, power, good quality or purity from the drug beyond the official or set up needs.” Even though the code makes this assertion, and if expanded on in the connected FDA Steering for Industry Container Closure Techniques for Packaging Human Prescription drugs and Biologics (May well 1999), there is no prescription provided in how to execute an extractables and leachables analysis, which happens to be, needless to say, An important facet of demonstrating suitability of container closure systems. Study More
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