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刊物信息

期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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OOS的统计判定策略及国内常见问题探讨

Discussion on the statistical decision strategy of out-of-specification(OOS) and the common problems in China

分类号:R917
出版年·卷·期(页码):2019,39 (10):1915-1920
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

对产品是否为不合格项(OOS)的准确判定,特别是对其测量属性接近其质量限的边缘产品的判定,是非常具有挑战性的问题。它不仅是质量控制中不可或缺的内容,更是检测实验室的能力体现。本文结合国际上合格性判定的相关法规和指导原则,从统计的不确定度和风险评估等角度,探讨了判断边缘产品是否属于OOS的几个基本前提要素,分析了目前国内在边缘产品的OOS判定中存在的常见问题,并用实例系统地阐述了相关判定策略,以期为今后OOS的科学判定提供依据。

-----英文摘要:---------------------------------------------------------------------------------------

Accurate determination is a particularly challenging issue whether a product is an OOS or not,especially when it is an edge product which the measurand is close to the specification limit. It is not only an indispensable part in quality control system,but also an indicator showing the ability of the testing laboratory. Based on the relevant regulations and guiding principles of international conformance decision,this paper discusses the premise elements to judge whether edge products belong to OOS or not from the perspectives of statistical (measurement uncertainty) and risk assessment,the common problems existing in the OOS decision of edge products in China,and also the systematically expounds the relevant decision strategies with examples,so as to provide the basis for the scientific decision of OOS in the future.

-----参考文献:---------------------------------------------------------------------------------------

[1] FDA.Guidance for Industry.Investigating Out-of-Specification(OOS) Test Results for Pharmaceutical Production[S/OL].2006[2019-06-06].http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070287.pdf
[2] HUM-MOLGEN.OOS Investigations in a GMP Environment[EB/OL].2015[2019-06-06].https://hum-molgen.org/meetings/courses/5350.html
[3] DOCPLAYER.OOS Forum Invitation.Prague,Czech Republic June 2012 ECA[EB/OL].2012[2019-06-06].https://docplayer.net/34066695-Oos-forum-invitation-prague-czech-republic-june-2012-eca.html
[4] 药品生产质量管理规范[S/OL].2010[2019-06-06].http://www.gov.cn/gongbao/content/2011/content_1907093.htm Good Manufacturing Practices[S/OL].2010[2019-06-06]. http://www.gov.cn/gongbao/content/2011/content_1907093.htm
[5] International Standard Organization(ISO)/International Electrotechnical Commission (IEC) 17025:2005.Accreditation Criteria for the Competence of Testing and Calibration Laboratories[S].2005
[6] 游赣花,谭德讲.药品质量控制过程中OOS分析存在的问题之管见[J].中国药事2015,29(10):58 YOU GH,TAN DJ.Some opinions about OOS investigations in pharmaceutical quality control[J].Chin Pharm Aff,2015,29(10):58
[7] 姜伟.药品检验机构OOS调查的关键点分析[C]//中国药学会第二届药物检测质量管理学术研讨会资料汇编.2015 JIANG W.Key points analysis of oos survey of drug testing institutions[C]//Compilation of the 2nd Symposium on Quality Control of Drug Testing in China Pharmaceutical Association.2015
[8] 周海江,雷丽娟.实验室检验与OOS/OOT结果调查分析[J].化工管理,2015(32):124 ZHOU HJ,LEI LJ.Laboratory testing and analysis of OOS/OOT results[J].J Chem Prin,2015(32):124
[9] American National Standards Institute(ANSI).The Expression of Uncertainty in Measurement[S].1993
[10] American Society of Mechanical Engineers.ASME B89.7.3.1:2001 Guidelines for Decision Rules:Considering Measurement Uncertainty,Determining Conformance to Specifications[S].2001
[11] American Society of Mechanical Engineers.ASME B89.7.4.1-2005 ASME Measurement Uncertainty and Conformance Testing:Risk Analysis[S].2005
[12] International Standard Organization(ISO).Guide to the Expression of Uncertainty in Measurement[S].1995
[13] International Standard Organization(ISO).10576_1 Statistical Methods-Guidelines for the Evaluation of Conformity with Specified Requirements[S].2003
[14] EURACHEM/CITAC Guide.Use of Uncertainty Information in Compliance Assessment[S/OL].2007[2019-06-06].https://www.eurachem.org/index.php/publications/guides/uncertcompliance
[15] Joint Committee for Guides in Metrology (JCGM).Evaluation of Measurement Data-The Role of Measurement Uncertainty in Conformity Assessment[S/OL].2012[2019-06-06].https://www.bipm.org/en/publications/guides/gum
[16] 中国合格评定国家认可委员会.CNAS-TRL-010:2019测量不确定度在符合性判定中的应用[S].2019 China National Accreditation Service for Conformity Assessment.CNAS-TRL-010:2019 Application of the Measurement Uncertainty in the Conformance Test[S].2019
[17] International Standard Organization(ISO).14253-1 Geometrical Product Specifications (GPS)-Inspection by Measurement of Workpieces and Measuring Equipment-Part 1:Decision Rule for Proving Conformance or Non-conformance with Specifications[S].1999
[18] DESIMONI E,BRUNETTI B.Uncertainty of measurement and conformity assessment:a review[J/OL].Anal Bioanal Chem,2011,400(6):1729[2019-06-06].http://xueshu.baidu.com/usercenter/paper/show?paperid=49a1b54b6e25010cbb8d32a683830168&site=xueshu_se&hitarticle=1
[19] International Laboratory Accreditation Cooperation.ILAC-G8-03 Guidelines on Assessment and Reporting of Conformity with Specification[S/OL].2009[2019-06-06].http://www.enao-eth.org/publication_documents/ILAC_G8_03_2009%20Guidelines%20on%20the%20reporting%20of%20compliance%20with%20specification.pdf
[20] ICH Guideline.Q2(R1) Validation of Analytical Procedures:Test and Methodology[S].2005
[21] 中华人民共和国药典2015年版.四部[S].2015:347 ChP 2015.Vol IV[S].2015:347
[22] USP 41-NF 36.<1210>Statistical Tools for Procedure Validation[S].2018:7622
[23] 谭德讲,朱容蝶,耿颖,等.判断定量类理化分析方法满足预期用途的标准探讨[J].药物分析杂志,2019,39(2):196 TAN DJ,ZHU RD,GENG Y,et al.Discussion about the criteria of quantitative physicochemical analytical methods for satisfying their intended use[J].Chin J Pharm Anal,2019,39(2):196
[24] 马莉,杨化新,谭德讲,等.药品质量标准中限度范围确立方式探讨[J].中国新药杂志2019,28(5):523 MA L,YANG HX,TAN DJ,et al.Discussion of establishment of acceptance criteria in drug specification[J].Chin J New Drugs,2019,28(5):523
[25] OMCL Network of the Council of Europe.Quality Management (QM) Documents[S/OL].[2019-06-06].https://www.edqm.eu/quality-management-guidelines-86.html
[26] 谭德讲,隋思涟,朱容蝶,等.理化方法验证统计分析软件的设计与功能[J].药物分析杂志,2019,39(2):223 TAN DJ,SUI SL,ZHU RD,et al.Design and function of statistical software for the validation of analysis methods[J].Chin J Pharm Analysis,2019,39(2):223
[27] Commission Decision of 12 August 2002 Implementing Council Directive 96/23/EC. Concerning the Performance of Analytical Methods and the Interpretation of Results[S/OL].2002[2019-06-06].http://eurlex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=en&type_doc=Decision&an_doc=2002&nu_doc=657
[28] 中国合格评定国家认可委员会.CNAS-CL01-G003测量不确定度的要求[S/OL].2019[2019-06-06].https://www.cnas.org.cn/rkgf/sysrk/rkyyzz/2019/04/896483.shtml China National Accreditation Service for Conformity Assessment.CNAS-CL01-G003 Requirements for Measurement Uncertainty[S/OL].2019[2019-06-06].https://www.cnas.org.cn/rkgf/sysrk/rkyyzz/2019/04/896483.shtml
[29] 中国合格评定国家认可委员会.CNAS-GL006化学分析中不确定度的评估指南[S].2019 China National Accreditation Service for Conformity Assessment.CNAS-GL006 Guidance on Quantifying Uncertainty in Chemical Analysis[S].2019

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