GOOD CHROMOTOGRAPHY PRACTICES优良色谱规范.docVIP

WHO 工作文件 QAS/19.791 GOOD?CHROMOTOGRAPHY?PRACTICES 优良色谱规范 (February2019) DRAFT FOR COMMENTS 征求意见稿 Description of?Activity?活动描述 Date?日期 Following?a recommendation by?the WHO Expert Committee?on Specifications for?Pharmaceutical ?Preparations (ECSPP)?byDr André?Van?Zyl,?a?member of the ECSPP, the WHO?Secretariat was recommended to develop ?a new?guidance ongood chromatography?practices. October?2018 WHO制剂标准专家委员会（ECSPP）建议，ECSPP成员Dr André Van Zyl建议WHO秘书处起草优良色谱规范指南 2018年10月 Preparation of?first draft?working?document. December ?2018 -February 2019 第一份工作文件草案起草 2018年12月-2019年2月 Mailing?of working document to theExpert Advisory?Panelon the?International Pharmacopoeiaand Pharmaceutical?Preparations ?(EAP) inviting?comments and posting of the?working?document on the WHO website for public?consultation. February– ?May 2019 将文件草案发给国际药典和药品专家顾问团(EAP)征求意见，在WHO官网上发布征求公众意见 2019年2-5月 Consolidation of comments receivedand?review of?feedbacks.Preparation?of working?document for discussion. June2019 整合收到的意见和反馈审核。起草工作供讨论。 2019年6月 Discussion?of working document and feedbacks ?received?duringthe informal?Consultation on Good Practices ?for?Health Products ?Manufacture?and?Inspection. July2019 讨论工作文件和优良药品生产与检查规范非正式咨询期间收到的反馈 2019年7月 Revision?of the working document ?based on comments?received ?during the informal Consultation on Good Practices?forHealth Products ?Manufacture and?Inspection. End ofJuly2019 根据优良药品生产与检查规范非正式咨询期间收到的建议修订工作文件 2019年7月底 Mailing?of?revised working documentto the ?EAP inviting?comments and posting the working?document ?on the WHO?website for public consultation. August – September 2019 将修订后的工作文件发给EAP征求意见，在WHO官网上发布工作文件征求公众意见 2019年8-9月 Consolidation of?comments receivedand?review of?feedbacks.Preparation?of working?document for discussion. End of September 2019 整合所收到的建议，审核反馈意见。起草工作文件供讨论 2019年9月 Presentation to the Fifty-fourth meeting of the ECSPP. 14 -18 October2019 提交第54次ECSPP会议 2019年10月14-18 Any other ?follow-up?action as required. 其它所需后续措施 1.????? INTRODUCTION AND SC