January 21, 2025 In 21 CFR 211.ninety four it is said that “Drug product or service containers and closures shall not be reactive, additive, or absorptive to alter the safety, identification, power, top quality or purity in the drug over and above the Formal or set up requirements.” When the code will make this assertion, and when expanded on in the connected FDA Steering for Business Container Closure Devices for Packaging Human Drugs and Biologics (Could 1999), there is absolutely no prescription provided in the way to execute an extractables and leachables evaluation, which happens to be, not surprisingly, A vital element of demonstrating suitability of container closure programs. Read through More
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