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FDA issues ICH Q10 guidance and Q4B annexes

This article was originally published in The Gold Sheet

Executive Summary

The International Conference on Harmonization Q10 quality systems guideline is now available in the form of FDA guidance, the agency said April 8. Also announced that day are three annexes to the ICH Q4B guideline for evaluation and recommendation of pharmacopoeial texts on microbiological examination of nonsterile products. They are for: microbial enumeration tests general chapter; tests for specified microorganisms general chapter; and acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use general chapter

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