标准编号:ISO 23419:2021

中文名称:中药 颗粒制造程序和质量保证的一般要求

英文名称:Traditional Chinese medicine — General requirements for manufacturing procedures and quality assurance of granules

发布日期:2021-12

标准范围

This document specifies general requirements for manufacturing procedures and quality and safety assurance of granules and compactates made from traditional Chinese medicine extracts or powder for oral use. This document excludes granules or compactates made from pure compounds (chemically defined) even if they are isolated as naturally occurring constituents of decoction pieces or crude herbal and mineral drugs.

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