质量风险管理在中药经营企业GSP实施中的应用
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篇名: 质量风险管理在中药经营企业GSP实施中的应用
TITLE:
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 reference for the implementation of quality risk management in GSP of TCM trading enterprises. METHODS: The necessity of quality risk management in TCM trading enterprises was introduced; by using the method of quality risk management, based on hazard analysis and critical control point (HACCP) tool, according to the actual situation of TCM trading enterprises, four key links including the critical control points during purchasing, receiving and acceptance, storage and maintenance, exwarehouse and transportation were identified and controlled. RESULTS & CONCLUSIONS: It is recommended that TCM trading enterprises take corrective measures aiming at the above four key links of risk control points like whether the procurement link was lawful and legal; how to control TCM acceptance quality; whether TCM maintenance method was valid; whether transportation and distribution affected the quality of goods. For this purpose, procurement link should be based on the establishment of legal purchase channels; the experience of TCM appearance and property acceptance should be gathered in receiving and acceptance link to guarantee the quality of warehoused drugs based on the requirements of the newly revised GSP; storage and maintenance link should take an effective control of temperature and humidity, and carry out the scientific maintenance; exwarehouse and transportation link should highlight the “green logistics”, accomplishing quality and non-pollution.
期刊: 2016年第27卷第22期
作者: 洪宏
AUTHORS: HONG Hong
关键字: 中药经营企业;质量风险管理;药品经营质量管理规范;应用
KEYWORDS: TCM trading enterprises; Quality risk management; GSP; Application
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