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News about GMP/cGMP

2009-12-22

FDA: New ICH Q4B Annexes 5, 8, 11 &12

FDA published recently the new ICH Q4B Annexes as Guidance for Industry.

 

The annexes 8, 11 & 12 of the ICH QB4 document "Evaluation and Recommendation of Pharmacopoeial Texts used in the ICH Regions" are not really new. They were already published by the ICH at its website.

With the US implementation  they were now published as Guidance for Industry at the FDA website

Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions

Source: FDA News websiteICH Quality Guidelines

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