质量风险管理在中药经营企业GSP实施中的应用

发布时间：2018-01-16 20:27

本文关键词：质量风险管理在中药经营企业GSP实施中的应用　出处：《中国药房》2016年22期 　论文类型：期刊论文

【摘要】：目的:为中药经营企业在《药品经营质量管理规范》(GSP)中实施质量风险管理提供参考。方法:介绍中药经营企业实施质量风险管理的必要性;并运用质量风险管理方法,结合危害分析和关键控制点工具,根据中药经营企业的实际情况,对采购、收货与验收、储存与养护、出库运输等4个关键环节中的关键控制点进行识别与控制。结果与结论:中药经营企业可针对上述4个关键环节的风险控制点,即购进渠道是否合法合规、中药验收质量如何控制、中药养护方法是否有效、运输配送是否影响商品质量来采取不同的纠偏措施。其中,采购环节应以建立合法购货渠道为基础;收货与验收环节应基于新版GSP的要求,积累中药外观性状的验收经验,保证入库药品的质量安全;储存与养护环节应有效控制温湿度,落实科学养护;出库运输环节应突出"绿色物流",做到不污染、不变质。
[Abstract]:Objective: to provide a reference for Chinese medicine enterprises to implement quality risk management in GSP.Methods: introduce the necessity of quality risk management in traditional Chinese medicine enterprises. And the use of quality risk management method, combined with hazard analysis and critical control point tools, according to the actual situation of traditional Chinese medicine enterprises, procurement, receipt and acceptance, storage and maintenance. Results and conclusion: TCM enterprises can control the risk control points of the four key links, that is, whether the purchase channel is legal or not. How to control the acceptance quality of traditional Chinese medicine, whether the maintenance method of traditional Chinese medicine is effective or not, whether the transportation and distribution affect the quality of goods to take different corrective measures. Among them, the purchasing link should be based on the establishment of legal purchasing channels; The receiving and acceptance should be based on the requirements of the new version of GSP, accumulate the acceptance experience of the appearance characters of traditional Chinese medicine, and ensure the quality and safety of the medicine in storage. Storage and maintenance links should effectively control temperature and humidity to implement scientific maintenance; Transportation links should highlight the "green logistics", so that no pollution, not deterioration.
【作者单位】：浙江英特医药药材有限公司;
【分类号】：F426.72;R288
【正文快照】： *执业药师。研究方向:药品经营质量管理。电话:0571-89982980。E-mail:25128952@qq.com质量风险管理是在整个药品生命周期中就药品的质量风险进行评估、控制、交流和审核的系统过程。美国FDA于2002年在药品质量管理体系中率先引入质量风险管理理念,后经不断完善目前已在药品研

【相似文献】