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什么是验证体系?验证项目流程
王宇光 / 2013-09-07

四平58同城 www.kdgn.net 验证体系 验证项目流程

 

 

CHAPTER ONE第一章                                                  11
What Is Validation ?验证定义                                        11
The Validation Categories验证分类                                 13
Systems, Utilities & Equipment Validation公用工程系统 设备验证    15
Design Qualification 设计确认                                     18
Develop Room Data                                                 20
Validation Master Plan验证总计划                                  23
Protocols方案                                                     23
Installation Qualification Protocol安装确认方案                   24
Operational Qualification Protocol运行确认方案                    25
Performance Qualification性能确认                                 25
Change Control/ Deviation变更控制、变差                           26
Cleaning Validation清洁验证                                       27
THE CLEANING VALIDATION MASTER PLAN清洁验证总计划                 28
Computer Validation计算机验证                                     30
Process Validation工艺验证                                        37
Analytical Validation分析方法验证                                 38
Utilities & Equipment Validation公用工程和设备验证                41
Levels of Validation Activities:                                  41
RETROSPECTIVE VALIDATION回顾性验证                                42
PROSPECTIVE VALIDATION验证计划                                    43
CONCURRENT VALIDATION同步验证                                     43
CHAPTER TWO第二章                                                  45
The History and Roots of Validation验证的由来                       45
Key Dates in the History of Validation验证史大事记                57
CHAPTER THREE第三章                                                58
Why Do We Validate?为什么验证                                       58
and How Much Does It Cost?验证的费用                                58
Why do we Validate ?为什么验证                                    58
The Law Appertaining to GMP验证是GMP法规的一部分                  61
How much does it all cost?需要花费多少钱                           64
CHAPTER FOUR第四章                                                 68
Who Is Responsible For Validation?谁是验证责任人                    68
The Validation effort验证准备                                     68
A: The dedicated working party专门的工作小组                      68
b: THE ROLE OF CONSULTANTS咨询顾问的角色                          71
C: Working party & Task groups工作小组和任务组                    71
The Qualified Person (QP)有资质的人                               72
CHAPTER FIVE第五章                                                75
How Does Validation Affect You?验证怎样影响你                      75
Training培训                                                      77
Federal Standards法规标准                                         79
MANUFACTURING PERSONNEL (COMPANY STRUCTURE)生产人员(组织结构)    80
CHAPTER SIX第六章                                                  83
Validation Policy, Strategy Protocols                              83
& The Validation Report验证制度、策略、方案、报告                    83
Validation Strategy验证策略                                       84
The Protocols验证方案                                             85
Types of validation protocols验证方案的类型                       86
The Validation Report验证报告                                     91
CHAPTER SEVEN第七单元                                              98
What Activities Support                                            98
The Validation Effort?验证工作需要哪些支持                           98
Users Requirement Specification用户需求                           99
Acceptance Criteria验收标准                                       99
Risk Assessment分析按评估                                        100
CHAPTER EIGHT第八单元                                             103
What are the Consequences of Not Validating ?如果没有验证会有什么结果103
CHAPTER NINE第九单元                                              109
Who Are We Validating For ?我们为了谁而验证                        109
Food & Drugs Administration - the FDA食品药品监督管理局          109
CHAPTER 10第十单元                                                114
Preparation of:准备                                                114
Standard Operating Procedures                                     114
& The Validation Master Plan.验证主计划和标准操作规程               114
STANDARD OPERATING PROCEDURE标准操作规程                         114
THE VALIDATION MASTER PLAN验证主计划                             123
Master Plan Review and Approvals主计划审核和批准                 123
Document Preparation Audit Trail文件的准备审计跟踪               125
Master Plan Revision History主计划修订历史                       126
Definitions术语                                                  127
Introduction概述                                                 128
Training培训                                                     135
Instrumentation设备列表                                          135
Planned Preventative Maintenance.设备维保计划                    136
Validation Approach -验证方法                                    137
CHAPTER eleven第十一单元                                           142
How Do We Plan And Programme Validation?如何计划规划               142
Planning and programming the validation effort起草和设计验证计划142
Time Scales时间安排                                              145
Protocol execution.方案的执行                                    146
CHAPTER TWELVE第十二单元                                           148
A LEXICON OF                                                      148
VALIDATION TERMINOLOGY验证术语                                    148
CHAPTER THIRTEEN第十三单元                                         159
STANDARD FORMS标准格式                                            159

 

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