Product Release

Parametric Release of Sterile Products
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Parametric Release of Sterile Products

Is parametric release an appropriate control strategy for sterile drug products that are not terminally sterilized?   No. Parametric release is only appropriate for terminally sterilized drug products. Although both terminally sterilized and aseptically processed drug product batches are required to meet the sterility test requirement (see 21 CFR 211.167(a)) before release to the market,…