cGMP Guidance: Sterile Drug Products Produced by Aseptic Processing
Abstract:cGMP Guidance: Sterile Drug Products Produced by Aseptic Processing
This guidance is proposed to aid manufacturers of sterile drug and biological products meet the FDA cGMP requirements when manufacturing these products under aseptic processing. This guidance replaces the 1987 Industry Guideline on Sterile Drug Products Produced by Aseptic Processing.
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