关于药品“产品合格证”的研究  

Study on “product qualification certificate” of drugs

作　　者：沈海宾 SHEN Haibin(Shanghai Fudan Forward Pharmaceutical Co.,Ltd.,Shanghai 201111,China)

机构地区：[1]上海复旦复华药业有限公司,上海201111

出　　处：《上海医药》2018年第19期67-69,共3页Shanghai Medical & Pharmaceutical Journal

摘　　要：药品"产品合格证"是在药品生产、经营、流通过程中证明药品合格的主要凭证之一,但在长期的实践中没有法规对其格式、内容等进行规范,使得流通企业、医院在入库验收时没有统一参照的验收标准。建议政府部门修订法规,对"产品合格证"的格式、内容等进行规范,使药品验收、入库、核对有统一的标准,否则,应取消"产品合格证"。＂Product qualification certificate＂ is one of the main credentials that certify the drug＇s qualification in the process of production, drug operation and circulation. However, there is no regulation to regulate its format and content in longterm practice. It makes the circulation enterprises and hospitals have no unified reference acceptance criteria at the time of storage acceptance. It is suggested that the government departnents should make amendments to the regulations, standardize the format and contents of the certificate so that there is a uniform standard for checking the acceptance of drugs, and on the contrary, we should clearly confirm the cancellation of the ＂ertificate＂.

关 键 词：药品 产品合格证 规范化 

分 类 号：R951[医药卫生—药学]