Issue Date: September 30, 2016
Issued by: Center for Biologics Evaluation and Research
Topic(s): ICH-Quality
Status: Final
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry
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. Additional Guidance Resources • Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers
Download the Guidance Document
