Tag: Current Good Manufacturing Practice Sterile Drug Products

Current Good Manufacturing Practice Sterile Drug Products

Guidance for Industry Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice I. IntroductionThis guidance is intended to help pharmaceutical manufacturers meet the requirements in the US FDA’S current good manufacturing practice (CGMP) regulations (2l CFR parts 210 and 211) when manufacturing sterile drug and biological products using aseptic processing. This guidance replaces the 1987 […]

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