计算机验证相关法规指南

仰望星星

与分析仪器验证有关的法规、质量管理标准和相关教科书有：

1. L. Huber, Validation and Qualification in Analytical Laboratories（分析实验室的认证和验证）, Interpharm,Informa Healtcare,New York,USA, 1998, Second revision 2007.（该书覆盖了分析实验室认证的所有方面，包括设备、分析方法、参考物质和人员资质等。）

2. C.C. Chan, H. Lam, Y.C. Lee, X.M. Zhang, Analytical Method Validation and Instrument Performance Verification（分析方法认证与仪器性能验证）, Wiley Interscience, Hoboken USA, 2004.（书中有几章推荐了仪器验证的实用方法。）

3. P. Coombes, Laboratory Systems Validation Testing and Practice（实验室系统认证试验与实践），DHI Publishing, LTD,Raleigh,USA2002（这是一本关于实验室系统认证测试与操作的书）

4. L. Huber, Validation of Computerized Analytical and Networked Systems（计算机分析与网络化系统认证）, Interpharm, Englewood, CO,USA, April 2002

5. P. Bedson and M. Sargent, The development and application of guidance on equipment qualification of analytical instruments（分析仪器设备验证指南的研究和应用）, Accreditation and Quality Assurance, 1(6),265-274, 1996

6. M. Freeman, M. Leng, D. Morrison and R.P. Munden from the UK Pharmaceutical Analytical Sciences Group (PASG), Position Paper on the qualification of analytical equipment（分析设备验证的意见书）, Pharm. Techn. Europe, 40-46, November 1995 (英国药物分析学组制定的关于分析仪器验证的纲领性文件，推出了分析仪器验证的4Q模型，即设计验证DQ、安装验证IQ、操作验证OQ、和性能验证PQ)

7. GAMP Good Automated Manufacturing Practice, A Risk-based Approach for Compliant GxP Computerized Systems, Version 5: 2008（自动化生产质量管理规范GAMP，GxP[url=]环境[/url]下基于风险的计算机系统认证方法，2008年第5版）

8. GAMP Good Practice Guide for Validation of Laboratory Systems（GAMP实验室系统质量管理指南），2005

9. Parenteral Drug Association (PDA), Validation and qualification of computerized laboratory data acquisition systems (实验室计算机数据采集系统的认证与验证，LDAS), Technical paper 31, 2000

10. Pharmaceutical Inspection Convention Scheme (PIC/S), Good practices for Computerised Systems in Regulated ‘GxP’ Environments (规范化GxP环境下计算机系统的质量管理)，2003

11. U.S. FDA, Title 21 of the U.S. Code of Federal Regulations: 21 CFR 211-Current good manufacturing practice for finished pharmaceuticals. ([url=]美国[/url]联邦管理法规第21篇：21CFR211-现行药品生产质量管理规范)

12. Unites States Pharmacopeia, Chapter <1058>, Analytical Instrument Qualification（美国药典通则<1058>分析仪器验证）, Rockville, USA, 2008

13. U.S. FDA GLP, Good laboratory practice regulations for non-clinical studies, Final rule（非临床研究的GLP法规，终槁）, U.S. FDA, Rockville, Md.,USA, Title 21 CFR, Part 58, 1979

14. United States Food and Drug Administration (FDA), General Principal of Software Validation: Final Guidance for Industry and FDA Staff (软件认证的一般原则：行业和FDA工作人员的最终指导), Rockville, MD, Jan 2002

15.U.S.FDA, Title 21 of theU.S.Code of Federal Regulations: 21 CFR 11-Electronic Records; Electronic SIgnatures. (美国联邦管理法规第21篇：21CFR11-电子记录与电子签名)

16. Organization of Economic Co-operation and Development, Good laboratory practice in the testing of chemicals, final report of the Group of Experts on Good Laboratory Practice, (世界经济合作与发展组织，化合物测试的GLP，GLP专家组最终报告) 1982

17. Organization of Economic Co-operation and Development, The OECD principles of good laboratory practice, Series on principles of good laboratory practice and compliance monitoring (世界经济合作与发展组织关于GLP的原则，GLP与认证监督的系列原则) , number 1, GLP consensus document environment monograph No. 45,Paris, 1998

18. Commission of the European Communities, The rules governing medicinal products in the European Union, Volume 4, Good manufacturing practices: Medicinal products for human and veterinary use（欧洲共同体委员会，欧盟药品管理制度第4卷，药品生产质量管理规范：人用与兽用药品）, 2003

19. Qulification and validation, Annex 15 to the EU Guide to Good Manufacturing Practice, 2001（欧盟GMP指南附录15，验证与认证）

20. ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients（ICH Q7A活性药物成分的生产质量管理指南）

21. ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories（[url=]检测[/url]和校准实验室能力的通用要求）, 2005

loveyujun131452

{:soso_e179:}

一沙一叶

这是哪个文件的参考资料啊

zhaoyongjie

高人，谢谢分享

彩虹

了解下{:soso_e181:}

guyue

高人啊，有机会都弄来看看。

syhorchid

不靠谱