摘要
Abstract
OBJECTIVE:To provide reference for the implementation of quality risk management in GSP of TCM trading enter-prises. 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 recommend-ed 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 es-tablishment 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;exware-house and transportation link should highlight the“green logistics”,accomplishing quality and non-pollution.关键词
中药经营企业/质量风险管理/药品经营质量管理规范/应用Key words
TCM trading enterprises/Quality risk management/GSP/Application分类
医药卫生
