论文部分内容阅读
杭州武林药店有限公司在2002年5月一次性通过了国家药品监督管理局GSP认证并取得了认证证书,是浙江省除试点企业以外首批通过的企业。本人一直在公司负责质量管理工作,并于2001年度参加杭州市零售药店验证换照的现场检查工作,总结这些年质量管理工作的开展和2002年认证中的经验与教训,现将如何开展GSP实施和认证的体会归纳如下,希望对同行业者会有所帮助。一、全面实施,端正观念,做好前期做准备工作与资料申报GSP强调的是药品经营全过程的质量管理,所以GSP涉及药品经营企业所有人员、所有环节,需要全员的参与和全方位的配合。
Hangzhou Wulin Pharmacy Co., Ltd. passed the GSP certification of the State Drug Administration once in May 2002 and obtained the certificate of certification. It is the first batch of enterprises in Zhejiang Province other than the pilot enterprises. I have been in the company responsible for quality management, and in 2001 to participate in Hangzhou retail pharmacies verify the site inspection work, summarize these years of quality management and certification in 2002 experience and lessons learned now how to carry out GSP implementation And certification experience summarized as follows, I hope the same industry will be helpful. First, the full implementation of the correct concept, do a good job preparatory work and information reporting GSP emphasizes the entire process of drug management quality management, so GSP involving pharmaceutical companies all personnel, all aspects of the need for full participation and all-round Cooperation.