目录

中文

1 Rationale and  Purpose of this Guide

1 本指南的目的和原理

1.1 How to Use  this Guide

1.1 如何使用该指南

1.2 This Guide is  not directly based on the 4Qs Model

1.2 该指南没有直接使用4Q模型

1.3 Scope: What’s  In and What’s Out

1.3 范围：包含什么以及不包含什么

1.3.1Computerised  System Validation (CSV) or Computer Software Assurance (CSA)?

1.3.1计算机系统验证(CSV)或计算机软件保证(CSA)

1.4 Links to  other ECA Guides

1.4 链接到其他ECA指南

2 Key  Regulations, Standards and Guidance Documents

2 关键法规、标准和指南文件

2.1 Good  Manufacturing Practice (GMP) Regulations and Guidance

2.1 GMP法规和指南

2.2 USP  <1058> Analytical Instrument Qualification

2.2 USP 《1058》分析仪器确认

2.3 Good  Laboratory Practice (GLP) Regulations and Guidance

2.3 GLP法规和指南

2.4 GAMP© 5 Guide  and Good Practice Guides

2.4 GAMP 5 指南和良好实践指南

2.5 Regulatory  and Industry Data Integrity Guidances

2.5 法规和行业数据可靠性指南

2.6 ISO/IEC  17025: 2017 General Requirements for the Competence of Testing and  Calibration Laboratories

2.6 ISO/IEC  17025:2017检测和校准实验室能力的一般要求

2.7 Official  Medicines Control Laboratories Guidance Documents

2.7 官方药物控制实验室指导文件

2.8 Traceable  Standards for Calibration of Instruments and Systems & ISO 17034:2017

2.8仪器和系统校准的可追溯标准& ISO 17034:2017

2.9 IUPAC  Compendium of Terminology in Analytical Chemistry & Eurachem Equipment  Qualification Draft Guide

2.9 IUPAC分析化学术语汇编和Eurachem设备确认指南草案

3 Brief History  of AIQ and AIQSV

3 分析仪器确认和分析仪器系统验证的简短历史

3.1 Equipment  Qualification

3.1 设备确认

3.2 Analytical  Instrument Qualification and USP <1058> 2008

3.2 分析仪器确认-USP <1058> 2008

3.3 Analytical  Instrument Qualification and USP <1058> 2017

3.3 分析仪器确认-USP<1058> 2017

3.4 Analytical  Instrument Qualification and System Validation: Updating USP <1058>

3.4 分析仪器确认和系统验证：更新USP<1058>

4 Roles and  Responsibilities in AIQSV

4 分析仪器系统验证的角色和职责

4.1 Laboratory  Roles

4.1 实验室角色

4.2 Quality Unit  or Quality Assurance

4.2 质量单元或质量保证

4.3 Information  Technology

4.3 信息技术

4.4 Purchasing

4.4 采购

4.5 Supplier

4.5 供应商

4.6 In-House  Metrology and / or CSV Groups

4.6 内部计量和/或CSV团队

4.7 Contractors /  Consultants

4.7 承包商/顾问

5 Role of AIQSV  in Ensuring Data Integrity

5 AIQSV在确保数据完整性中的作用

5.1 Data  Integrity Model

5.1数据完整性模型

5.2 Important of  AIQSV for Ensuring Data Integrity

5.2 AIQSV对确保数据完整性的重要性

5.3 Importance of  Adopting AIQSV as Part of an Analytical Procedure Lifecycle (APL) Approach

5.3 采用AIQSV作为分析方法生命周期(APL)方法部分的重要性

6 Analytical  Instrument Qualification and System Lifecycle Process Flow

6分析仪器确认和系统生命周期流程

6.1 Fitness for  Intended Use versus Fitness for Intended Purpose

6.1预期用途适应度与预期目的适应度

7 Risk-Based Classification  of Analytical Instruments and Systems

7基于风险的分析仪器和系统分类

7.1 Definition of  Intended Use is Critical

7.1预期用途的定义至关重要

7.2 Definition of  Groups A, B and C

7.2 A、B、C分类的定义

7.3 Sub-Division  of Group A Apparatus

7.3 A类分组

7.4 Sub-Division  of Groups B and C

7.4 B类和C类分组

8 System Risk  Assessment

8 系统风险评估

8.1  Identification of the Item and a Statement of Intended Use

8.1物品的标识和预期用途说明

8.2 Does the Item  Carry Out any GMP Activities?

8.2该项目是否执行GMP活动?

8.3 Is the Item  Only Software?

8.3 这个项目仅仅是软件吗？

8.4 Is the Item  USP <1058> Group A?

8.4 是USP<1058> A类吗？

8.5 Is the Item  Group B (Instrument) or Group C (System)

8.5 是USP<1058>B类或C类吗？

8.6 Group C  Systems – How Much Validation Should I Do?

8.6 C类系统—应该做哪些验证？

8.7 Qualification  and Validation Statement

8.7 确认和验证报告

8.8 Instrument  and System Inventory

8.8 仪器和系统清单

8.9 Integrated  Validation Document

8.9 综合的验证文件

9 Why Do We Need  an AIQSV Lifecycle?

9 为什么我们需要分析仪器确认系统验证生命周期？

9.1 Lifecycle  Approaches for Analytical Procedures and Analytical Instruments & Systems

9.1分析程序和分析仪器与系统的生命周期方法

9.2 Control of  Lifecycle Processes

9.2生命周期工艺的控制

10 Lifecycle  Stage 1:  Specification and Selection

10 生命周期阶段1：规格和选择

10.1 Introduction

10.1 介绍

10.2 A Documented  User Requirements Specification is a Statement of Intended Use

10.2文档化的用户需求规范是预期用途的声明

10.3 Supplier  Selection and Qualification Process

10.3 供应商选择和确认流程

10.4 System Risk  Assessment

10.4 系统风险评估

10.5  Identification of Critical Instrument Controls and Parameters Including Data  Integrity Functions

10.5关键仪器控制和参数的识别，包括数据完整性功能

10.6 Purchase and  Receipt of the Instrument or System

10.6购买和接收仪器或系统

11 Lifecycle  Stage 2:  Qualification/Validation of  Instruments and Systems

11生命周期阶段2:仪器和系统的确认/验证

11.1 Introduction

11.1 介绍

11.2 Calibration  and Qualification of Instruments Using Traceable Standards & CRMs

11.2使用可追溯标准和对仪器进行校准和确认

11.3 System  Suitability Test / Point of Use Checks

11.3系统适用性测试/使用点检查

11.4 Plan the  Work to Be Performed

11.4计划要执行的工作

11.5 Supplier  Installation and Commissioning

11.5 安装和调试

11.6 Prototyping  and Configuring the System

11.6 系统设计和配置

11.7 Updating the  URS

11.7 URS更新

11.8 Requirements  Traceability

11.8 需求追溯

11.9 User  Acceptance Testing (Performance Qualification)

11.9 用户验收测试（性能确认）

11.10 Write  Procedures and User Training

11.10 编写程序和用户培训

11.11 Establish  the Instrument Logbook

11.11 建立仪器日志

11.12 Operational  Release for Routine Use

11.12 日常使用操作放行

11.13 Validation  of Multiple Instances of the Same Group C System Software

11.13 同类C组系统软件的验证

12 Lifecycle  Stage 3:  Continued Performance  Verification

12 生命周期第3阶段：持续性能确认

12.1 Introduction

12.1 介绍

12.2 Operational  SOPs and Training

12.2 操作SOP和培训

12.3 Operational  Use of Instrument Logbooks

12.3仪器日志的操作使用

12.4 Routine  Monitoring Through Trend Analysis

12.4 通过趋势分析进行日常监控

12.5 Preventative  Maintenance, Repair, Calibration and Requalification

12.5预防性维护、维修、校准和再确认

12.6 Change  Control and Configuration Management

12.6 变更控制和配置管理

12.7 Monitoring  IT Support

12.7监控IT支持

12.8 Periodic  Review & Revalidation

12.8定期审查和再验证

12.9 Migration or  Archiving of Data and Records

12.9数据和记录的迁移或归档

12.10 Retirement  of the Instrument or System

12.10仪器或系统的退役

13 How To  Appendices

13 如何使用附录

13.1  Introduction: Interpretation and Risk Management

13.1 介绍：解释和风险管理

14 Appendix 1:  Group A; Apparatus

14 附录1：A类设备

14.1 Appendix 1: Group  A1;  Vortex Mixer

14.1 附录1，A1: 旋涡振荡器

14.2 Appendix 1:  Group A2; Volumetric Glassware;   Burette or Pipette

14.2 附录1: A2; 玻璃器皿；滴管或移液器

15 Appendix 2:  Group B Instruments

15 附录2：B类仪器

15.1 Appendix 2:  Group B1; pH meter

15.1 附录2：B1 ；pH计

15.2 Appendix 2:  Group B2; Autotitrator

15.2 附录2：B2；自动滴定仪

15.3 Appendix 2:  Group B3; Dispenser Dilutor and Management of User Defined Programs

15.3附录2: B3;用户自定义程序的分配器、稀释器

16 Appendix 3:  Analytical Balance Grouping is Dependent on Intended Use

16 附录3：分析天平分组依赖于预期用途

16.1 Common  Instrument Specification for all Examples

16.1所有示例的通用仪器规格

16.2 Analytical  Balance Group B1

16.2 分析天平B1类

16.3 Analytical  Balance Group B2

16.3 分析天平B2类

16.4 Analytical  Balance Groups B1 and C2

16.4 分析天平B1和C2类

17 Appendix 4:  Group C Systems

17 附录4：C类系统

17.1 Group C1;  Standalone UV-Visible Spectrometer Using an Integrated Validation Document

17.1 C1类：使用集成的独立紫外-可见光谱仪验证

17.2 From Group  C1 to C3; Bioassay Analysis Software

17.2 从C1到C3；生物测定分析软件

18 Appendix 5:  Chromatography From Group B Instrument to Group C Networked System

18 附录5：色谱从B类仪器到C类联网系统

18.1 Group B Type  1: Liquid Chromatograph Specification

18.1 B类1型：液相色谱仪

18.2 Lifecycle  Phases for the Instrument and CDS .

18.2 仪器和CDS的生命周期阶段。

18.3 Service  Level Agreement with an IT or SaaS Service Provider

18.3与IT或SaaS服务提供商签订的服务水平协议

19 Appendix 6:  Group C3 NIR spectrometer for identification of raw materials using macros

19附录6: C3近红外光谱仪的确认

19.1 Management  of User Defined Macros

19.1 自定义宏的管理

20 Technical  Glossary

20 技术术语

20.1 Terms

20.1 术语

20.2  Abbreviations

20.2 缩略语

21 References

21 参考文件