Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (APIs)

• By: Staff Editor
• Date: April 17, 2017
• Source: http://www.fda.gov

Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (APIs)

The quality and the stability of Active Pharmaceutical Ingredients (APIs) are vital for the overall quality, safety and efficacy of human drug products. Thus, APIs for pharmaceutical use and those used for manufacturing drugs for clinical trials are highly regulated. The US FDA has had an extensive set of GMP requirements for APIs for several decades now and still guidelines are continually being revised.

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