内容提示: ECA Validation Good Practice Guide Table of Contents 1.0 Introduction 2.0 A new view on Validation: The move to process understanding 3.0 Examples: How to do 3.1 Risk-based Approach to Process Validation 3.2 Risk-based Qualification 3.3 Statistics in Process Validation and Continued ...
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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...
The ECA Validation Group was established with the goal togather knowledge on validation, for example by continuously developing aProcess Validation Good Practice Guide. The summary below will provide moredetails about recent and future activities. ECA验证组建立的目标是收集验证方面的知识,例如持续发展的工...
1.1 How to Use this Guide 如何使用本指南 1.2 This Guide is not directly based on the 4Qs Model /本指南并非直接基于4Qs模型 1.3 Scope: What’s In and What’s Out 范围:有啥没啥列表 1.3.1 Computerised System Validation (CSV) or Computer Software Assurance (CSA)? 计算机系统验证(CSV)还是计...
• colleagues on the USP Validation and Verification Panel and the USP Statistics Subcommittee. USP确认和验证专家组和USP 统计专家组。 Those involved in the core team were; 核心团队成员: Regulatory References Test Results for Pharmaceutical Production,US FDAEvaluation and Research (CDER), October...
Good Distribution Practice APIs/Excipients Packaging/Packaging Materials Development Regulatory Affairs Computer Validation/IT Compliance Qualified Person (QP) Medical Devices GMP Basic Training Courses Other Manufacturing Areas Top Events View all GMP Courses and Conferences ...
Determination of the scope and extent of qualification and validation activities确认和验证活动范围和程度确定 Monitoring and sampling processes监测和取样程序 Document reviews文件审核 Supplier Qualification供应商确认 Material Management物料管理 Making justification wi...
“…some of the principles and guidance, such as contamination control strategy, design of premises, cleanroom classification, qualification, validation, monitoring and personnel gowning, may be used to support the manufacture of other products that are not intended to be sterile such as certain ...
General method 2.4.20 "Determination of elemental impurities" describes, amongst other things, method development and validation 通用方法2.4.20“元素杂质检测”描述了,除其内容外,方法开发和验证 The now obsolete heavy metal test (2.4.8) will be removed f...