PIC Plans Harmonized GMP Guide

24 June 1997

A draft of an internationally harmonized guide on Good ManufacturingPractice of active pharmaceutical ingredients is to be launched for comment by the Pharmaceutical Inspection Convention in September. The deadline for comments will be March 1, 1998.

The draft guide has been drawn up by a working group sponsored by PIC and the Pharmaceutical Inspection Cooperation Scheme, comprised of representatives of regulatory authorities from the Asian-Pacific Economic Cooperation group, China, the European Union, India, PIC-PIC/S, the US Food and Drug Adminitration and the World Health Organization.

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