White Paper

Good Manufacturing Practice Guidance For Active Pharmaceutical Ingredients

Source: Food and Drug Administration (FDA)
This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess. Submitted by the Food and Drug Administration (FDA)
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