1．コンピュータバリデーション入門
Contents
1. Copyright eCompliance 2012 58 FS WM Copyright eCompliance 2012 59 GAMP 5 5 i x _ _ __ a Copyright eCompliance 2012 60 Specification amp Verification Approach_ Copyright eCompliance 2012 612. pox 3 DQ IQ OQ 6 i OO ee a a XE PQ DQ IQ OQ lt _ GMP Copyright eCompliance 2012 17 Table of contents 1 2 3
3. p 24 Copyright eCompliance 2012 Total 4 eno Total Variation Copyright eCompliance 2012 25 Total Variation lt Copyright eCompliance 2012 26 27 Copyright eCompliance 2012 Table of contents 1 2 3 CSV 4 GAMP 5 28 Copyright eCompliance 2012 1 FDA BLUE BOOK Guide to Inspection of Computerized System in Drug Processing
4. Intended Use Copyright eCompliance 2012 45 a GAMP Copyright eCompliance 2012 46 GAMP5 Main Body GAMP 5 Table of Contents 1 Introduction 2 Key Concepts 3 Life Cycle Approach 4 Life Cycle Phases Quality Risk Management Regulated Company Activities Supplier Activities Efficiency Improve
5. SME Subject Matter Expert 1 2 IT 3 4 CVQA Computer Validation Quality Assurance SME SME Na e e SME _ AN EE
6. PMA Computerized System Validation CSV FDA General Principles of Software Validation 2001 EU GMP ANNEX11 11 3 GMP
7. Qualification DQ IQ OQ PQ DQ Copyright eCompliance 2012 12 GMP 13 11 2 1200 GMP Qualification Copyright eCompliance 2012 13 gt
8. Project PGION EA Retire i Tr Copyright eCompliance 2012 57 4 4 ST ST ST ST UAT UAT UAT UAT
9. Copyright eCompliance 2012 V Model GAMP 4 a Copyright eCompliance 2012 63 V Model GAMP 5 8 Copyright eCompli Non configured Software 3 SIRT 7 QMS gt Copyright eCompliance 2012 65 Configured Software 4 E nT QMS Copyright eCompliance 2012 66 Custom Software 5 Copyright eCompliance 2012 67
10. Copyright eCompliance 2012 40 GAMP 5 Bigger Picture em IT GMP GSMP Copyright eCompliance 2012 41 HIPPA GxP ASTM S85795 CMM ITLT Sox 42 Copyright eCompliance 2012 Copyright eCompliance 2012 43 GAMP GAMP 4 5GAMP 5 GAMP 4 GAMP Guide for Validation of Automated Systems 2001 12 GAMP 5 A Risk Based Approach to Compliant GxP Computerized Systems 2008 8 Automated Systems Computerized Systems Validation Copyright eCompliance 2012 44
11. Copyright eCompliance 2012 GMP NO 2 Copyright eCompliance 2012 GMP
12. Copyright eCompliance 2012 14 Crtical Non Crtical Direct Impact 23 Indirect Impact No Impact Copyright eCompliance 2012 GMP Copyright eCompliance 2012 SS
13. GAMP 5 5 mm QMS Quality Management System QMS QMS SME CSV i Copyright eCompliance 2012 53 GAMP 5 5
14. 0330001 149 e 2004 11 44 1 2005 3 25 ER ES 57 2003 5 23 Copyright eCompliance 2012 32 FDA Guidance for Industry Computerized Systems used in
15. Copyright eCompliance 2012 39 3 PLC PLC 5 Qualification DQ IQ OQ PQ _ 3 IQ OQ 2 ER ES IT
16. Copyright eCompliance 2012 22 PQ PQ PQ e OQ OQ e OQ SOP Copyright eCompliance 2012 23 PQ
17. Copyright eCompliance 2012 2 GAMP 1 FDA 21 CFR 211 68 Automatic mechanical and electronic equipment GMP PIC S 2011 1 39 2005 FDA 2011 2011 FDA 21 CFR Part 11 1997 3 20 Electronic Records Electronic Signatures 1997 8 20 14 1997 7 FDA Computerized Systems used in Clinical Trials CSV Copyright eCompliance 2012 30
18. 1 2012 5 18 http eCompliance co jp Copyright eCompliance 2012 CSV ER ES General Principles of EU GMP Annex11 Software Validation Computerised 22 10 21 Final Guidance for Systems Industry and FDA Staff 2011 1 13 2002 1 11 21 CFR Part 11 Electronic Records Electronic Signatures 1997 3 20 17 4 1 PICS S GUIDANCE GOOD PRACTICES FOR COMPUTERIZED SYSTEMS IN REGULATED GXP ENVIKONMENTS Copyright eCompliance 2012 2 CSV ER ES ASTM E2500 Standard Guide for Specification Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment 2007 American Society for es
19. HPLC GC UV pH HPLC GC IR UV TOC LIMS MRP2 MES ERP SCADA EDMS DCS IT Copyright eCompliance 2012 56 GAMP 5 5 GAMP 5 4
20. Coklhitesuitosp PV GR CSV _ GMP GMP gt Copyright eCompliance 2012 9 ANNEX 11 Where a computerised system replaces a manual operation there should be no resultant decrease in prodauct guality or guality assurance Copyright eCompliance 2012 Validation Validation Test Verification Qualification Certificate Audit Review Qualification Verification Copyright eCompliance 2012 11
21. OQ OQ gt Copyright eCompliance 2012 21 OQ Q OQ FMEA FTA
22. 3 102 2000 5 31 ISPE GAMP 4 GAMP Guide for Validation Of Automated SystemSs Good Automated Manufacturing Practice Version 4 General Principles of Software Validation Final Guidance for Industry and FDA Staff Version 2 0 Version 1 1 1997 6 9 2003 6 4 FDA Guidance for Industry Part 11 Electronic Records Electronic SignatureSs and Application Part11 PIC S Good Practice for Computerized System in Regulated 2004 7 1 GxP EnviromentS ANNEX11 Copyright eCompliance 2012 31 4
23. e QMS CSV Copyright eCompliance 2012 54 GAMP 4 GAMP 5 RFA Mastucture SoRwar 8 a Non configured Software gt 2 ii EA 8 COnfigured Software Custom Software gt Copyright eCompliance 2012 PLC
24. 2012 4 1 FDA PIC S ICH 2 PIC S PIC S ANNEX 11 2011 6 30 Copyright eCompliance 2012 35 Table of contents 1 2 3 CSV Copyright eCompliance 2012 36 GAMP Good Automated Manufacturing Practice 1990 FDA MCA Medicines Control Agency GAMP 1 1994 2 2 10 ISPE GAMP 4 FDA 1991 1994 1996 i Draft Supplier Supplier Supplier Guide Guide SupPlier Supplier Guide FDA GAMP1 GAMP2 Guide Sul
25. CSV 4 GAMP 5 Copyright eCompliance 2012 18 Qualification 1O Q PO Copyright eCompliance 2012 IQ IQ IQ 20 Copyright eCompliance 2012
26. 2007 5 11 Clinical Investigations Computerized Systems used in Clinical Trials EMEA GCP IWG Inspectors Working Group 2007 6 14 Reflection Paper on Expectations for Electronic Source Documents a Used in Clinical Trials 2008 4 31 2007 11 1 Ne 2007 12 21 2008 2 ISPE GAMP 5 A Risk Based Approach to Compliant GxP Computerized Systems FDA PIC S PMDA 2008 4 EDC ER ES Copyright eCompliance 2012 33 EU GMP EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Draft Annex 11 Computerised Systems ANNEX11 2008 10 31 PMDA 2008
27. 6 13 GLP 5 10 13 2 1 http Www pmda dgO jp operations Shonin outline ShinrasShinrai_6 file glp_list pdf PMDA EDC EDC http www pmda go jp operations shonin outline shinrailchecklist html FDA 21 CFR Part 11 http www fda gov AboutFDA CentersOffices CDER ucm204012 htm 2008 4 8 2009 10 2010 7 8 Copyright eCompliance 2012 34 6 2010 7 16 8 20
28. de GAMP5 GAMP3 GAMP4 Copyright eCompliance 2012 37 GAMP 5 A Risk Based Approach to Compliant GxP Computerized Systems GAMP5 GAMP 5 is a major revision and S aimed at enabling innovation and cost effective compliance Sion Wyn Editor of GAMP 5 2008 2 28 FDA PIC SG CSV Copyright eCompliance 2012 38 GMP GMP 4 PTP PLC HPLC GC IR UV pH TOC Excel ERP MES LIMS DCS EDMS SCADA
29. ments Copyright eCompliance 2012 47 GAMP5 Appendices AppendiceSs Management Appendices Development Appendices Operation ADpendices Special Interest Topics ADpendices General ADpendices CAPA Copyright eCompliance 2012 48 GAMP 5 5 QMS Life Cycle Approach within QMS Scalable Life Cycle Activities Process and Product Understanding Science Based Quality Risk Management Leveraging Supplier Involvement
30. ting and Materials GAMP 5 A Risk Based Approach to Compliant GxP Computerized Systems 2008 8 ISPE Copyright eCompliance 2012 3 Computerized System Validation CSV Copyright eCompliance 2012 4 Table of contents CSV GAMP 5 1 2 4 Copyright eCompliance 2012 FDA Guidelines on General Principles of Process Validation 1987 Establishing documented evidence which provides a high dedree of assurance that a specific process wl consistently produce a product meeting its predetermined speclifications and guality characteristics Average 3 Std Dev Averadge Average 3 Std Dev 99 73 Copyright eCompliance 2012 6 GMP 5
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