序号 | 章节 | 页码 | 认领人 |
1 | 1 Introduction | 7 | |
1.1 Overview | 7 |
1.2 Purpose | 7 |
1.3 Objectives for this Guidance | 8 |
1.4 Scope. | 9 |
1.5 Benefits | 12 |
1.6 Structure of this Guide | 13 |
1.7 Key Concepts | 14 |
2 | 2 The Validation Lifecycle | 17 | |
2.1 Project Delivery Planning | 19 |
2.2 Design Phase Items | 21 |
2.3 Commissioning and Qualification Plan | 24 |
2.4 Procurement and Construction | 25 |
3 | 2.5 Commissioning and Qualification | 25 | |
4 | 2.6 Track One – Traditional Approach to Qualification | 38 | |
5 | 2.7 Track Two – The Quality Risk Management Approach | 42 | |
6 | 2.8 Sampling | 56 | |
2.9 Performance Qualification | 58 |
2.10 Project Completion and Document Delivery | 60 |
2.11 Performance Qualification Final Reports | 60 |
2.12 On-Going Quality Monitoring | 61 |
2.13 Periodic Performance Evaluation or Periodic Review (PR) | 61 |
7 | 3 Appendix 1 – Typical WFI Generation and Distribution System Component Classification Example | 67 | |
4 Appendix 2 – Process Water, Pure Steam, and Process Steam | 73 |
4.1 Non-Monographed/Non-Compendial Water | 74 |
4.2 Steam | 76 |
8 | 5 Appendix 3 – System Classifications at Points of Use (POUs)/Sub-Loop | 81 | |
6 Appendix 4 – Typical Specifications for Water and Steam Systems | 87 |
6.1 Introduction | 88 |
6.2 User Requirements | 89 |
6.3 Functional Design Specification | 90 |
6.4 Detailed Design Specification | 91 |
8 | 7 Appendix 5 – Sampling and Testing Plan | 93 | |
8 Appendix 6 – Sample Turnover Package Requirements | 97 | |
9 | 9 Appendix 7 – References | 102 | 不翻译 |
10 | 10 Appendix 8 – Glossary | 105 | |
10.1 Acronyms and Abbreviations | 106 |
10.2 Definitions | 109 |
2.按划分的序号认领;