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NSF/IPEC/ANSI 363-2014

Practices (GMP) for Pharmaceutical Excipients

This Standard is intended to define Good Manufacturing Practices (GMP) for excipient manufacture and distribution for use in drug products. It sets minimum requirements for GMP applicable to all commercially available excipients.


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As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.

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