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什么是驗證體系?驗證項目流程
王宇光 / 2013-09-07

驗證體系 驗證項目流程

 

 

CHAPTER ONE第一章                                                  11
What Is Validation ?驗證定義                                        11
The Validation Categories驗證分類                                 13
Systems, Utilities & Equipment Validation公用工程系統 設備驗證    15
Design Qualification 設計確認                                     18
Develop Room Data                                                 20
Validation Master Plan驗證總計劃                                  23
Protocols方案                                                     23
Installation Qualification Protocol安裝確認方案                   24
Operational Qualification Protocol運行確認方案                    25
Performance Qualification性能確認                                 25
Change Control/ Deviation變更控制、變差                           26
Cleaning Validation清潔驗證                                       27
THE CLEANING VALIDATION MASTER PLAN清潔驗證總計劃                 28
Computer Validation計算機驗證                                     30
Process Validation工藝驗證                                        37
Analytical Validation分析方法驗證                                 38
Utilities & Equipment Validation公用工程和設備驗證                41
Levels of Validation Activities:                                  41
RETROSPECTIVE VALIDATION回顧性驗證                                42
PROSPECTIVE VALIDATION驗證計劃                                    43
CONCURRENT VALIDATION同步驗證                                     43
CHAPTER TWO第二章                                                  45
The History and Roots of Validation驗證的由來                       45
Key Dates in the History of Validation驗證史大事記                57
CHAPTER THREE第三章                                                58
Why Do We Validate?為什么驗證                                       58
and How Much Does It Cost?驗證的費用                                58
Why do we Validate ?為什么驗證                                    58
The Law Appertaining to GMP驗證是GMP法規的一部分                  61
How much does it all cost?需要花費多少錢                           64
CHAPTER FOUR第四章                                                 68
Who Is Responsible For Validation?誰是驗證責任人                    68
The Validation effort驗證準備                                     68
A: The dedicated working party專門的工作小組                      68
b: THE ROLE OF CONSULTANTS咨詢顧問的角色                          71
C: Working party & Task groups工作小組和任務組                    71
The Qualified Person (QP)有資質的人                               72
CHAPTER FIVE第五章                                                75
How Does Validation Affect You?驗證怎樣影響你                      75
Training培訓                                                      77
Federal Standards法規標準                                         79
MANUFACTURING PERSONNEL (COMPANY STRUCTURE)生產人員(組織結構)    80
CHAPTER SIX第六章                                                  83
Validation Policy, Strategy Protocols                              83
& The Validation Report驗證制度、策略、方案、報告                    83
Validation Strategy驗證策略                                       84
The Protocols驗證方案                                             85
Types of validation protocols驗證方案的類型                       86
The Validation Report驗證報告                                     91
CHAPTER SEVEN第七單元                                              98
What Activities Support                                            98
The Validation Effort?驗證工作需要哪些支持                           98
Users Requirement Specification用戶需求                           99
Acceptance Criteria驗收標準                                       99
Risk Assessment分析按評估                                        100
CHAPTER EIGHT第八單元                                             103
What are the Consequences of Not Validating ?如果沒有驗證會有什么結果103
CHAPTER NINE第九單元                                              109
Who Are We Validating For ?我們為了誰而驗證                        109
Food & Drugs Administration - the FDA食品藥品監督管理局          109
CHAPTER 10第十單元                                                114
Preparation of:準備                                                114
Standard Operating Procedures                                     114
& The Validation Master Plan.驗證主計劃和標準操作規程               114
STANDARD OPERATING PROCEDURE標準操作規程                         114
THE VALIDATION MASTER PLAN驗證主計劃                             123
Master Plan Review and Approvals主計劃審核和批準                 123
Document Preparation Audit Trail文件的準備審計跟蹤               125
Master Plan Revision History主計劃修訂歷史                       126
Definitions術語                                                  127
Introduction概述                                                 128
Training培訓                                                     135
Instrumentation設備列表                                          135
Planned Preventative Maintenance.設備維保計劃                    136
Validation Approach -驗證方法                                    137
CHAPTER eleven第十一單元                                           142
How Do We Plan And Programme Validation?如何計劃規劃               142
Planning and programming the validation effort起草和設計驗證計劃142
Time Scales時間安排                                              145
Protocol execution.方案的執行                                    146
CHAPTER TWELVE第十二單元                                           148
A LEXICON OF                                                      148
VALIDATION TERMINOLOGY驗證術語                                    148
CHAPTER THIRTEEN第十三單元                                         159
STANDARD FORMS標準格式                                            159

 

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