验证和确认之间的联系5.Validation.PDF

Annex 4 附件 4 Supplementary guidelines on good manufacturing practices validation 药品生产质量管理规范补充指南 ：验证 1 Introduction 简介 2 Scope 范围 3 Glossary 术语 4 Relationship between validation and qualification 验证和确认之间的联系 5. Validation 5.1. Approaches to validation 验证方法 5.2. Scope of validation 验证范围 5 Qualification 确认 6 Calibration and verification 校准和核实 7 Validation master plan 验证主计划 8 Qualification and validation protocols 确认和验证方案 9 Qualification and validation reports 确认和验证报告 10 Qualification stages 确认程序 11 Change control 变更控制 12 Personnel 人员 References 参考文献 Appendix 1 附录1 Validation of heating, ventilation and air-conditioning systems 采暖、通风和空气净化系统的验证 Appendix 2 附录2 Validation of water systems for pharmaceutical use 制药用水系统的验证 Appendix 3 附录3 Cleaning validation 清洁验证 Appendix 4 附录4 Analytical method validation 分析方法验证 Appendix 5 附录5 Validation of computerized systems 计算机系统的验证 Appendix 6 附录6 Qualification of systems and equipment 系统和设备的确认 Appendix 7 附录7 Non-sterile process validation 非灭菌工艺的验证 1. Introduction 简介 Validation is an essential part of good manufacturing practices (GMP). It is, therefore, an element of the quality assurance programme associated with a particular product or process. The basic principles of quality assurance have as t heir goa l t he prod uct io n of prod ucts t hat a re fit f or t heir intended use. These principles are as follows 验证是药品生产管理规范 （GMP ）的一个重要组成部分 ；也正因如此 ，所以它同时 也是产品或工艺的质量保证计划的一个不可或缺的要素。质量保证的基本原则以生 产出符合设计用途的产品为 目的 ，它的主要内容为 ： Quality, safety and efficacy must be designed and built into the product. 要事先设计质量、安全和效力 ，并使之在产品中实现。 Quality cannot be inspected or tested into the product. 不能仅仅只考察和检验成 品的质量。 Each critical step of the manufacturing process must be validated. Other steps in the process must be under control to maximize the probability that t