Process Validation Guidance GHTF/SG3/N99-10:2004 Study Group 3 Introduction Purpose Scope of SG3/N99 What is process validation? How are processes validated? What processes must be validated? How to maintain state of validation Revalidation GHTF SG3 Training : Toronto May 14-16, 2009 2 SG3/...
GHTF-SG3-N99-10-2004过程确认指南-英文文.doc,GHTF/SG3/N99-10:2004 (Edition 2) FINAL DOCUMENT Title: Quality Management Systems - Process Validation Guidance Authoring Group: SG3 Endorsed by: The Global Harmonization Task Force Date: Edition 2 - January 20
GHTF/SG3/N99-10:2004 (Edition 2) FINAL DOCUMENT Title: Quality Management Systems - Process Validation Guidance Authorin g Group: En dorsed by: Date: SG3 The Global Harmonization Task Force Edition 2 - January 2004 Taisuke Hojo, GHTF Chair The document herein was produced by the Global Har...
内容提示: GHTF/SG3/N99-10:2004 (Edition 2) FINAL DOCUMENT Title: Quality Management Systems - Process Validation Guidance Authoring Group: SG3 Endorsed by: The Global Harmonization Task Force Date: Edition 2 - January 2004 Taisuke Hojo, GHTF Chair The document herein was produced by the ...
“QualityManagementSystems–ProcessValidationGuidance”,originallyfinalizedin1999,isbeingrepublishedas“GHTF/SG3/N99-10:2004(Edition2)”afterrevisionsduetothechangesinISO13485:2003,whichisutilizedinsomeregulatorysystems.TheProcessValidationGuidancehasbeenrevisedinsections0through3.4,Figure1andAnnexB.Therevisionscanbe...
内容提示: GHTF/SG3/N99-10:2004 (Edition 2) FINAL DOCUMENT Title: Quality Management Systems - Process Validation Guidance Authorin g Group: En dorsed by: Date: SG3 The Global Harmonization Task Force Edition 2 - January 2004 Taisuke Hojo, GHTF Chair The document herein was produced by the...
GHTF/SG3/N99-10:2004 (Edition 2) FINAL DOCUMENT Title:Quality Management Systems - Process Validation Guidance 质量管理系统-过程验证指南 Authoring Group:SG3 Endorsed by:The Global Harmonization Task Force Date:Edition2 - January 2004 Taisuke Hojo, GHTF Chair The document herein was produced by ...
【中文版】GHTF Process Validation guidance工艺验证指南
第10页 Guidance on the control of products and services obtained from suppliers. GHTF/SG3/N17R9:2008 December 11, 2008 Page 10 of 21 Describe what is to be obtained (1) Identify potential suppliers(s) (3) Identify controls (5) EXAMPLES OF OBJECTIVE EVIDENCE Identify technical and process ...
ProcesscontrolValidationaverageusedSealervariationproductresultsQuality 系统标签: 英文版validation指南ghtf验证validations GHTF/SG3/N99-10:2004(Edition2)FINALDOCUMENTTitle:QualityManagementSystems-ProcessValidationGuidanceAuthoringGroup:SG3Endorsedby:TheGlobalHarmonizationTaskForceDate:Edition2-January2004TaisukeHojo,GHTF...