计算机术语 验证 validation,验证和确认之间的联系5.Validation.PDF

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