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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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