浅谈GMP认证中存在的问题
GM,,GMP认证；,软件；验证；实施；存在问题,1人员,2文件制定,3验证,4实施过程,参考文献：
摘要：GMP认证制度是国家对药品生产企业监督检验的一种手段，也是保证药品质量的一种科学、先进的管理方法。企业在GMP认证和实施的过程中，存在着与GMP要求不相符合的现象。人们对GMP的认识还有待于提高，我国的GMP认证管理工作应进一步加强。关键词：GMP认证； 软件；验证；实施；存在问题
Discussion on the Problem Existed in GMP Certification
YANG Xiaochen
(Henan Advanced Craftsman Training School of Pharmacy, Kaifeng 475003, China)
Abstract:GMP certification system is not only a kind of methods supervising pharmaceutical enterprises in our country, but also scientific and advanced management to guarantee drugs' quality. During the certificating and practicing of GMP, there are some phenomenons which don't correspond to requirement of GMP. People should improve their realization about GMP. The administration of national GMP certification should be also strengthened.
Key words:GMP certification;Software; Verification; Practice; Existing problem
药品生产质量管理规范(GMP)认证是国家对药厂能否提供符合GMP要求药品的监督检查措施 ......
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