分析方法转移内容介绍
Introduction to the concept and content of analytical method transfer
分类号：
出版年·卷·期（页码）：2015,35 (1):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
有关药品分析方法转移的相关指导原则和技术文件目前国内尚属鲜见,很多药品监管机构、实验室质量控制人员,甚至药品检验人员对方法转移的概念理解不清,方法转移的具体内容和适用范围不明,给分析检测及管理工作带来不便.本文在系统调研国际上有关分析方法转移标准规范内容的基础上,结合中国药品检验工作的实际情况需要,梳理药品检验相关方法转移的概念,介绍日常药品检验工作中的方法转移内容和步骤,为相关工作提供参考.
-----英文摘要：---------------------------------------------------------------------------------------
Currently there are few official documents available in China that can be used as a guide for analytical method transfer.A lot of confusion and misunderstanding of analytical method transfer exists among China regulatory authorities,laboratory quality management staff and scientists,consequently,lots of problems occur in the daily work of drug quality control and management.This paper surveys the international guidelines of analytical method transfer and clarifies the concept of method transfer and then illustrates the procedure of analytical method transfer with the aim to provide guidance for related work.
-----参考文献：---------------------------------------------------------------------------------------
[1] Guidance for Industry:Analytical Procedures and Methods Validation:Chemistry,Manufacturing,and Controls and Documentation [EB/OL].2000 [2014-08-01].http://www.drugfuture.com/library/ShowArticle.asp?ArticleID=69
[2] Guidance for Industry:Bioanalytical Method Validation [EB/OL].2001 [2014-07-21].http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm368107.pdf
[3] Guidance on Validation of Analytical Procedures:Text and Methodology [EB/OL].2003 [2014-07-18].http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002662.pdf
[4] WHO Technical Report Series 937 [EB/OL].2006 [2014-08-03].http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf?ua=1
[5] IP 4 [S].2006
[6] EP 7.1 [S].2011:3
[7] JP 16 [S].2011:2159
[8] General Requirements for the Competence of Testing and Calibration Laboratories(ISO/IEC 17025) [EB/OL].2005 [2014-07-12].http://www.iso.org/iso/catalogue_detail.htm?csnumber=39883
[9] Pappa H,Transfer of Analytical Procedures:A Proposal for a new general information chapter [J].USP Pharmacopeial Forum,2009,35(6):1380
[10] Validation of Analytical Methods [EB/OL].2010 [2014-07-10].http://www.docin.com/p-722893056.html
[11] USP 35-NF 30 [S].2012:503
欢迎阅读《药物分析杂志》！您是该文第 2694位读者！
