Tag: Time limitations in sterile dosage form manufacturing process

Guidelines In Pharma Time limitations in sterile dosage

Guidance for Sterile Pharmaceutical Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice TIME LIMITATIONS  FOR COMPLETION OF STEPS IN PHARMACEUTICAL PROCESS 21 CFR 211.111 states that “When appropriate, time limits for the completion of each phase of production shall be established to assure the quality of the pharmaceutical drug product. Deviation from […]

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