Friday, August 25, 2023

Time limitations in Sterile dosage form manufacturing

 The regulation 21 CFR 211.111 outlines that time limits for each phase of production must be established to ensure the quality of drug products. These time limits can be deviated from if it doesn't compromise product quality, but such deviations need to be justified and documented. Specifically, in aseptic processing, time limits should be set for stages like compounding, sterilization, filtration, product exposure, and equipment storage. These time limits should be backed by data, considering factors like bioburden and endotoxin load. Filters used for clarification or particle removal should also have established use times. This regulation falls under current good manufacturing practice (cGMP) in the pharmaceutical industry.

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