This page also includes the following information related to CGMP compliance:
The Agency has set up an establishment evaluation system (EES) which is described at the CDER EES site.
- FDA is developing a guidance document on the Manufacture, Process or Holding of Active Pharmaceutical Ingredients (APIs). This is a combined effort of the Centers for Drug Evaluation and Research, Biologics Evaluation and Research, and Veterinary Medicine, in cooperation with the Office of Regional Operations.
Inspection Guidelines and Guidances
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