2017年国家食品药品监督管理总局通告安徽省中药饮片不合格情况分析

摘要

目的 为中药饮片质量监管提供思路与对策.方法 以2017年国家食品药品监督管理总局门户网站发布的21期中药饮片不合格通告中标示生产企业或供货单位为安徽省境内的不合格批次作为切入点, 分析不合格项目产生的原因.结果 未严把中药材质量关、未严格按照炮制工艺生产、未严格执行成品放行程序、未按质量要求贮存养护、非法生产经营行为是造成中药饮片不合格的主要原因.结论 监管部门应注重源头引导, 严格全过程监管, 构建社会共治格局, 加大培训和规范指导, 切实保证中药饮片质量安全, 造福于民.%Objective To provide solutions for the supervision of Prepared slices of crude medicine. Methods Based on the 21 unqualified medicines announcements issued by CFDA, of which are manufactured or supplied in Anhui province, the reasons of unqualified products are analyzed. Result The main reasons of unqualified products are found as the manufactures don't control the quality of crude medicine strictly, don't produce the products according to the procedure, don't execute the release procedure, and don't store the products in accordance with required storage conditions and illegal business. Conclusion Regulatory authority should focus on the guidance of enterprises, supervise the entire manufacturing process, and increase the GMP training opportunity, to ensure the quality of prepared slices of crude medicine, build a social co-governance community and serve the people.