分析方法验证国内外技术指南现状分析
|
摘要
分析方法验证是保证检测方法准确可靠的重要步骤,对确保产品质量稳定可靠不可或缺。各国药典和相关组织很早就开始研究和规范方法验证的内容,并随着科技的进步,不断地完善。本文对分析方法验证的主要技术指南进行概述和分析,为读者更好地了解各国对药品分析方法验证指南的修订历程与要求提供参考。
Method validation is an important step for ensuring the accuracy and reliability of a testing method and then for guaranteeing the quality of a product. The pharmacopoeias in various countries and relevant organizations had already studied and standardized the contents of method validation for long time,and have continuously improved the contents with the progress of science and technology. In this paper,the main guidelines were summarized and analyzed about the validation of analytical procedure and it is helpful for readers to better understand the revision process and requirements of the guidelines in various countries.
Method validation is an important step for ensuring the accuracy and reliability of a testing method and then for guaranteeing the quality of a product. The pharmacopoeias in various countries and relevant organizations had already studied and standardized the contents of method validation for long time,and have continuously improved the contents with the progress of science and technology. In this paper,the main guidelines were summarized and analyzed about the validation of analytical procedure and it is helpful for readers to better understand the revision process and requirements of the guidelines in various countries.
引文
[1]International Organization for Standardization(ISO).Life Cycle of ISO9000:2015[S/OL].[2018-12-01].https://www.iso.org/standard/45481.html
[2]International Organization for Standardization(ISO).Validation(3.8.13).ISO 9000:2015:Quality Management Systems—Fundamentals and Vocabulary[S].2015
[3]Food and Drug Administration of the United States of America(USA-FDA):Analytical Procedures and Methds Validation for Drugs and Biologics Guidance for Industry[S/OL].(2015)[2018-12-01].https://www.fda.gov/RegulatoryInformation/Guidances/default.htm
[4]王萍萍,张媛,谭德讲,等.药典方法验证的最新研究进展[J].中国新药杂志,2016,25(9):985WANGPP,ZHANGY,TANDJ,etal.Latestprogressof compendial procedure validation[J].Chin J New Drugs,2016,25(9):985
[5]ASTM E29-13(2013)Standard Practice for Using Significant Digitsin Test Data to Determine Conformance with Specifications[S].2013
[6]ASTM E1488-12(2018)Standard Guide for Statistical Procedures to use in Developing and Applying Test Methods[S].2018
[7]ASTM E2782-2011 Standard Guide for Measurement Systems Analysis(MSA)[S].2011
[8]<1225> Validation of compendial Procedures[J/OL].USP Pharmacopeial Forum,2016,42(2)[2018-12-01].http://www.usppf.com/pf/pub/index.html
[9]USPⅩⅫ[S].1990:1710(General Chapter <1225> Validation of Compendial Methods)
[10]USPⅩⅩⅣ[S].2000:2149(General Chapter <1225> Validation of Compendial Methods)
[11]USP31-NF26[S].2008:687(GeneralChapter<1226>Verification of Compendial Procedures)
[12]USP 35-NF 30[S].2012:876(General Chapter <1224> Transfer of Analytical Procedures)
[13]<1200> Requirements for Compendial Procedures[J/OL].USPPharmacopeial Forum,2013,39(6)[2018-12-01].http://www.usppf.com/pf/pub/index.html
[14]<1210> Validation of Compendial Procedures[J/OL].USP Pharmacopeial Forum,2014,40(5)[2018-12-01].http://www.usppf.com/pf/pub/index.html
[15]USP 41-NF 36[S].2018:7623(<1210> Statistical Tools for Procedure Validation)
[16]OMCL Network of the Council of Europe.PA/PH/OMCL(13)82 2R.Validation of Analytical Procedures[EB/OL].(2014)[2018-12-01].https://www.edqm.eu/en/quality-management-guidelines-86.html
[17]OMCL Network of the Council of Europe.PA/PH/OMCL(14)89R.Evaluation and Reporting of Results.Annex 2A:Examples ofRe-Test Programmes for Quantitative Tests[EB/OL].(2015)[2018-12-01].https://www.edqm.eu/en/quality-management-guidelines-86.html
[18]ICH Harmonised Tripartite Guideline.Q2(R1)Validation of Analytical Procedures:Text and Methodology[S].(2005)[2018-12-01].http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html
[19]ICH Press Release:ICH Prepares for future new topics[EB/OL].(2018)[2018-12-01].https://www.ich.org/ichnews/press-releases/view/article/ich-assembly-kobe-japan-june-2018.html
[20]中华人民共和国药典2000年版.二部[S].2000:附录ⅩⅨAChP 2000.VolⅡ[S].2000:AppendixⅩⅨA
[21]中华人民共和国药典2015年版.四部[S].2015:374(9101)ChP 2015.VolⅣ[S].2015:374(9101)
[22]DESIMONI E,BRUNETTI B.Uncertainty of measurement and conformity assessment:a review[J].Anal Bioanal Chem,2011,400(6):1729
[23]GB/T 27417-2017合格评定化学分析方法验证和验证指南[S].2018GB/T 27417-2017 Guideline for Validation and Verification ofanalytical Methods[S].2018.
[24]GB/T 19000-2016质量管理体系基础和术语.3.8.13[S].2016(idt ISO 9000:2015)GB/T 19000-2016Quality Management Systems—Fundamentalsand Vocabulary.3.8.13[S].2016
[24]谭德讲,杨化新,张河战.对Validation,Verification and Qualification三个质量管理术语之理解[J].中国药事,2013,27(1):22TAN DJ,YANG HX,ZHANG HZ.Understanding the terms ofvalidation,verification and qualification in quality management[J].Chin Pharm Aff,2013,27(1):22
[26]中华人民共和国药典2015年版.四部[S].2015:374(9102)ChP 2015.VolⅣ[S].2015:374(9102)
[2]International Organization for Standardization(ISO).Validation(3.8.13).ISO 9000:2015:Quality Management Systems—Fundamentals and Vocabulary[S].2015
[3]Food and Drug Administration of the United States of America(USA-FDA):Analytical Procedures and Methds Validation for Drugs and Biologics Guidance for Industry[S/OL].(2015)[2018-12-01].https://www.fda.gov/RegulatoryInformation/Guidances/default.htm
[4]王萍萍,张媛,谭德讲,等.药典方法验证的最新研究进展[J].中国新药杂志,2016,25(9):985WANGPP,ZHANGY,TANDJ,etal.Latestprogressof compendial procedure validation[J].Chin J New Drugs,2016,25(9):985
[5]ASTM E29-13(2013)Standard Practice for Using Significant Digitsin Test Data to Determine Conformance with Specifications[S].2013
[6]ASTM E1488-12(2018)Standard Guide for Statistical Procedures to use in Developing and Applying Test Methods[S].2018
[7]ASTM E2782-2011 Standard Guide for Measurement Systems Analysis(MSA)[S].2011
[8]<1225> Validation of compendial Procedures[J/OL].USP Pharmacopeial Forum,2016,42(2)[2018-12-01].http://www.usppf.com/pf/pub/index.html
[9]USPⅩⅫ[S].1990:1710(General Chapter <1225> Validation of Compendial Methods)
[10]USPⅩⅩⅣ[S].2000:2149(General Chapter <1225> Validation of Compendial Methods)
[11]USP31-NF26[S].2008:687(GeneralChapter<1226>Verification of Compendial Procedures)
[12]USP 35-NF 30[S].2012:876(General Chapter <1224> Transfer of Analytical Procedures)
[13]<1200> Requirements for Compendial Procedures[J/OL].USPPharmacopeial Forum,2013,39(6)[2018-12-01].http://www.usppf.com/pf/pub/index.html
[14]<1210> Validation of Compendial Procedures[J/OL].USP Pharmacopeial Forum,2014,40(5)[2018-12-01].http://www.usppf.com/pf/pub/index.html
[15]USP 41-NF 36[S].2018:7623(<1210> Statistical Tools for Procedure Validation)
[16]OMCL Network of the Council of Europe.PA/PH/OMCL(13)82 2R.Validation of Analytical Procedures[EB/OL].(2014)[2018-12-01].https://www.edqm.eu/en/quality-management-guidelines-86.html
[17]OMCL Network of the Council of Europe.PA/PH/OMCL(14)89R.Evaluation and Reporting of Results.Annex 2A:Examples ofRe-Test Programmes for Quantitative Tests[EB/OL].(2015)[2018-12-01].https://www.edqm.eu/en/quality-management-guidelines-86.html
[18]ICH Harmonised Tripartite Guideline.Q2(R1)Validation of Analytical Procedures:Text and Methodology[S].(2005)[2018-12-01].http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html
[19]ICH Press Release:ICH Prepares for future new topics[EB/OL].(2018)[2018-12-01].https://www.ich.org/ichnews/press-releases/view/article/ich-assembly-kobe-japan-june-2018.html
[20]中华人民共和国药典2000年版.二部[S].2000:附录ⅩⅨAChP 2000.VolⅡ[S].2000:AppendixⅩⅨA
[21]中华人民共和国药典2015年版.四部[S].2015:374(9101)ChP 2015.VolⅣ[S].2015:374(9101)
[22]DESIMONI E,BRUNETTI B.Uncertainty of measurement and conformity assessment:a review[J].Anal Bioanal Chem,2011,400(6):1729
[23]GB/T 27417-2017合格评定化学分析方法验证和验证指南[S].2018GB/T 27417-2017 Guideline for Validation and Verification ofanalytical Methods[S].2018.
[24]GB/T 19000-2016质量管理体系基础和术语.3.8.13[S].2016(idt ISO 9000:2015)GB/T 19000-2016Quality Management Systems—Fundamentalsand Vocabulary.3.8.13[S].2016
[24]谭德讲,杨化新,张河战.对Validation,Verification and Qualification三个质量管理术语之理解[J].中国药事,2013,27(1):22TAN DJ,YANG HX,ZHANG HZ.Understanding the terms ofvalidation,verification and qualification in quality management[J].Chin Pharm Aff,2013,27(1):22
[26]中华人民共和国药典2015年版.四部[S].2015:374(9102)ChP 2015.VolⅣ[S].2015:374(9102)