WHO数据与记录管理规范指南征求意见稿讲述.docVIP

GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT PRACTICES DRAFT FOR COMMENT  HYPERLINK /wiki/index.php?title=WHO_Guidance_on_Good_Data_and_Record_Management_Practices_cn \o WHO Guidance on Good Data and Record Management Practices cn 　CN　　EN　2015/09? HYPERLINK /wiki/images/8/84/Guidance-on-good-data-management-practices_QAS15-624pdf \t new [pdf]?? HYPERLINK /medicines/areas/quality_safety/quality_assurance/Guidance-on-good-data-management-practices_QAS15-624pdf?ua=1 原文地址?Working document QAS/15.624 Should you have any comments on the attached text, please send these to Dr S. Kopp, Group Lead, Medicines Quality Assurance, Technologies, Standards and Norms ( kopps@ ) with a copy to Ms Marie Gaspard ( gaspardm@ ) by 30 November 2015 . Medicines Quality Assurance working documents will be sent out electronically only and will also be placed on the Medicines website for comment under “Current projects”. If you do not already receive our draft working documents please let us have your email address (to bonnyw@ ) and we will add it to our electronic mailing list. SCHEDULE FOR THE PROPOSED ADOPTION PROCESS OF DOCUMENT QAS/15.624: GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT PRACTICES Proposal and need for new guidance document discussed at the informal consultation on inspection, good manufacturing practices and risk management guidance in medicinesmanufacturing28–30 April 2014Concept paper drafted and proposal presented by Mr I. Thrussell, Expert Inspector, Prequalification Team (PQT)-Inspection to the forty-ninth meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations13–17 October 2014Preparation of draft document by Mr I. Thrussell in close cooperation with colleagues from PQT-Inspection and a drafting group, including Ms M. Cahilly and national inspectorsOctober 2014–June 2015Draft discussed at consultation on data management, bioequivalence, good manufacturing practices and medicines inspection29 June–1 J