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关于世界卫生组织药物生产资格预认证的实践

Practices Learned from Prequalification of Medicines Programme of World Health Organization

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【作者】 王玲胡廷熹

【Author】 WANG Ling1,HU Tingxi2(1.Nanjing Baijingyu Pharmaceutical Co.,Ltd.,Nanjing 210038,China;2.China Pharmaceutical University,Nanjing 210009,China)

【机构】 南京白敬宇制药有限责任公司中国药科大学

【摘要】 由世界卫生组织开展的药物生产资格预认证项目是一个有利于提高国内制药企业GMP水平的项目,也是国内制药企业参与国际招标,走向国际的一条优选之路。论述药物生产资格预认证项目对国内制药企业发展的积极作用,并浅谈在实践该项目过程中的经验和体会,为国内制药企业参加该项目提供参考。

【Abstract】 The prequalification of medicines programme(PQ) developed by World Health Organization(WHO) is a programme which can promote the level of good manufacturing practice(GMP) for domestic pharmaceutical enterprises.It is also a preferred path for domestic pharmaceutical enterprises to participate in the international bidding and go toward internationalization.The positive effects of PQ on the development of domestic pharmaceutical enterprises were discussed,as well as the experience and understandings from the practices of PQ were introduced,so as to provide references for domestic pharmaceutical enterprises participating in PQ.

  • 【文献出处】 药学进展 ,Progress in Pharmaceutical Sciences , 编辑部邮箱 ,2013年02期
  • 【分类号】F426.72;R95
  • 【下载频次】83
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