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China’s GMPs Stringent, But Still Gaps Between ICH Q7; Revisions Expected

This article was originally published in PharmAsia News

Executive Summary

While Chinese GMPs for API suppliers have more stringent requirements governing personnel and sterility requirements for clean rooms, the ICH Q7 guideline has stricter rules for in-process controls and reprocessing of solvents, according to Li Ting of DSM Anti-Infectives

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