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‘Informal’ ICH Panel Mulling Revision, Rewrite of Q7 Guideline on API GMPs: FDA Official

Aug. 8, 2012
An informal working group of the International Conference on Harmonisation (ICH) is looking into revising or rewriting the “dated” Q7 standard on good manufacturing practices for active pharmaceutical ingredients (API), which may need clarification, an FDA official says. Industry representatives and regulators from the U.S., EU and Japan are developing a concept paper on the need for a new formal ICH Q7 expert working group as the original panel that brought the guideline into being has since moved on and the standard is now more than a decade old, Robert Yetter, associate director for review management at CDER, said.
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