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Good Manufacturing Practices for Pharmaceutical Excipients in China

Source:
2019/12/11 13:45
[Abstract]:

For downloading the full document, please click here.

 

       为加强药用辅料的生产质量管理,保证药用辅料质量,国家局在充分征求各方面意见的基础上,于 2006 年 3 月 23 日制定了《药用辅料生产质量管理规范》。


To enhance manufacturing quality management of pharmaceutical excipients and ensure quality of pharmaceutical excipients, State Food and Drug Administration (SFDA), on the basis of extensive solicitation of opinions of all circles, has formulated Good Manufacturing Practices for Pharmaceutical Excipients on 23th March, 2006.

 

       为进一步促进国内外关于药用辅料生产质量管理的法规交流,现 IPEC 中国组织会员单位对其进行了英文翻译。特此感谢参与此次翻译的IPEC 中国会员:


To further promote the exchange of regulations on the manufacturing quality management of pharmaceutical excipients at home and abroad, IPEC China organize the members to translate the Good Manufacturing Practices for Pharmaceutical Excipients (2006 version) into English. Great thanks the  members below for participating in this translation.

 

 

    默克化工技术(上海)  有限公司-王昱
    默克化工技术(上海)  有限公司-刘慧
    科莱恩化工(中国)有限公司-李娜
    罗辅医药科技(上海)有限公司-高闪
    博爱新开源制药股份有限公司-王晓燕
    赛诺菲(中国)投资有限公司-阮克萍
    杜邦(上海)实业有限公司-陶征宇
    江苏力凡胶囊有限公司-汤瑛

 

 

  Merck Chemicals (Shanghai) Co.,Ltd.  Bree Wang
  Merck Chemicals (Shanghai) Co.,Ltd.   Helen Liu
  Clariant Chemicals (China) Ltd.   Lina Li
  Ron Pharm(Shanghai) Co., Limited  Shine Gao
  BOAI NKY PHARMACEUTICALS LTD.   Xiaoyan Wang
  Sanofi China Investment Co., Ltd  Alice Ruan
  DuPont (Shanghai) Enterprise Co., Ltd.  Martin TAO
  Jiangsu Lefan Capsule Co.,L TD.  Ying Tang

 

       同时感谢高闪进行了编辑整理。如果您认为该文件中有任何内容翻译不够准确或难以理解,请提出您宝贵的意见。我们将进行搜集和整理,确认后另行修订。


Meanwhile, thank Shine Gao for editing and summarizing. If you find any content in this document is  not translated accurately or understandable, please give us your valuable comments. We will collect and revise them after confirmation.

 

       附件:2006 版《药用辅料生产质量管理规范》(英文)
Attachment: Good Manufacturing Practices for Pharmaceutical Excipients (2006 version) in English

 

 

国际药用辅料协会(中国)IPECAssociation(China) Limited
2019年 11月 27日 27th November,2019

 

 

 

 

 

Notice on Printing and Distributing Good Manufacturing Practice for
Pharmaceutical Excipients


 

No.: Guo Shi Yao Jian An [2006] 120

 

(Food and) Drug administration of each province, autonomous region and municipality directly under the Central Government,

 

To enhance manufacturing quality management of pharmaceutical excipients and ensure quality of pharmaceutical excipients, State Food and Drug Administration (SFDA), on the basis of extensive solicitation of opinions of all circles, has  formulated Good Manufacturing Practices for Pharmaceutical Excipients, which is hereby printed and distributed to you for your reference in implementation with the local practical conditions taken into account. Should you have any opinion or suggestion in the process of implementation, please timely contact SFDA Department of Drug Safety & Inspection.

 

State Food and Drug

Administration

March 23, 2006

For downloading the full document, please click here.