论文部分内容阅读
我院的制剂工作,经过1983年制剂整顿后,近几年主要是贯彻《药品管理法》,特别是按“药品生产质量管理规范(GMP)”要求,狠抓了基础建设,新建制剂大楼,增换设备,建立健全规章制度和目标管理,岗位责任制,使药局的工作逐步走上了正轨。目前,灭菌制剂成品合格率平均达97%以上,普通制剂达100%,没有发生过由制剂本身所致的热原反应,获得了临床使用的信赖。1987年以来,经总后卫生部组织的全军和广州军区制剂质量抽验合格率为100%,今年被评为全军十二佳制剂单位,我院的做法和体会如下: 一、认真学习、宣传、贯彻《药品管理法》
In our hospital preparations, after the preparations for rectification in 1983, mainly in recent years, the implementation of the “Drug Administration Law”, in particular, “Drug Manufacturing Quality Management Practices (GMP)” requirements, pay close attention to infrastructure, building new agents, Exchange equipment, establish and improve the rules and regulations and objectives of management, job responsibility system, so that the work of the pharmacy gradually put on track. At present, the qualified rate of the finished products of sterilized preparations reaches above 97% on average, and the ordinary preparation reaches 100%. No pyrogen reaction caused by the preparation itself has been obtained and the trust of clinical use has been obtained. Since 1987, the quality of the whole army and the Guangzhou Military Region organized by the General Post-Post-Ministry of Health has passed the 100% pass. This year, it was rated as one of the 12 best preparation units in the PLA. The practice and experience of our hospital are as follows: 1. To study hard, Publicize and implement the “Drug Administration Law”