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Gaps Between ICH Q7 and China's GMPs Described

This article was originally published in The Gold Sheet

Executive Summary

While the Chinese GMPs for API suppliers have more stringent requirements governing personnel and sterility requirements for cleanrooms, the ICH Q7 guideline has stricter rules for in-process controls and reprocessing of solvents, according to Li Ting of DSM Anti-Infectives. She discussed these "gaps" at the 11 APIC/CEFIC European conference on APIs Oct. 23 in Paris. Ting works for DAI China, a new business unit of DSM. DAI China is located in Beijing, with two facilities in northern China that manufacture penicillin and cephalosporin products

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