摘要
目的加强药品经营企业GSP认证后的监管。方法论述了GSP认证对企业产生的效果,分析了GSP认证后存在的问题及原因,提出强化监管的措施与对策。结果与结论依法解决企业是药品质量第一责任人的问题;对企业实行信用等级管理;尽快修订GSP标准;切实提高GSP检查员的能力,才能保证GSP认证工作的健康发展。
Objectives Strengthen supervision of drug enterprises after the GSP certification. Methods On the GSP certification of the results generated by the enterprise, the problems existing in the GSP certification and their reasons were analyzed, and the measures and countermeasures strengthening supervision of drug enterprises were put forward. Results and Conclusions Solving the problem that the enterprice is the first responsible owner of the drug quality. Implementing the degrees managements for the enterprice. Revising the GSP criterion as soon as possible. Enhancing the ability of GSP instectors, to make the authentication of GSP developing healthfully.
出处
《中国药事》
CAS
2009年第8期743-744,共2页
Chinese Pharmaceutical Affairs
关键词
药品
GSP认证
监管
措施
对策
drug
GSP certification
supervision
measure
countermeasure
