ECA在2023年12月发布了一份验证指南，《分析仪器确认和系统验证指南》，该指南英文全文153页。
先说大家关心的，在公众号主页回复关键词“分析仪器”即可下载。
本ECA指南描述并讨论了根据仪器规格规定、采购、调试、校准或验证正确操作的生命周期过程。配置应用和控制软件，确保分析仪器和系统的持续运行，以及仪器或系统的退役。本指南的主要重点是在药品GMP法规下运行的分析仪器和控制它们的系统。
本指南旨在提供当前法规指南和最佳实践的概要和讨论，以便实验室用户可以决定科学合理和适当的确认方法，以确保分析仪器和系统符合其特定的质量管理体系(QMS)和符合性要求。”
目录已匆匆翻译，大家可凑合着看看：
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 |
趣谈HMI、触摸屏、PLC的关系
