who验证指南2016年版.docxVIP

1. INTRODUCTION 简介 1.1 Validation is an essential part of good practices including good manufacturing practices (GMP) (4) and good clinical practices (GCP). It is therefore an element of the pharmaceutical quality system. Validation, as a concept, incorporates qualification and should be applied over the life cycle of, e.g. the applicable product, process, system, equipment or utility. 验证是包括GMP和GCP在内的良好规范的必要部分。因此是制药质量体系的组成部分。验证这个概念包括确认并且应该在产品、工艺、系统、设备或设施的整个生命周期中被使用。 1.2 These guidelines cover the general principles of validation and qualification. In addition to the main part, appendices on validation and qualification (e.g. cleaning, computer and computerized systems, equipment, utilities and systems, and analytical methods) are included. 这个指南包括验证和确认的一般原则。除了主体部分外，还包括确认和验证附件（如清洁、计算机和计算机化系统、设备、设施和系统以及分析方法）。 1.3 The following principles apply: 适用的原则如下: ? the execution of validation should be in compliance with regulatory expectations; 验证的执行应该符合监管预期 ? quality, safety and ef?cacy must be designed and built into the product; 质量、安全和效力应该被设计和构建到产品中 ? quality cannot be inspected or tested into the product; 质量不能通过检查或测试赋予产品? quality risk management principles should be applied in determining the need, scope and extent of validation; 应该应用质量风险管理规则来决定验证的需求、范围和程度 ? ongoing review should take place to ensure that the validated state is maintained and opportunities for continuing improvement are identified. 应该进行持续的回顾来确保维持验证状态并识别持续改进的机会 1.4 The implementation of validation work requires considerable resources such as: 验证工作的完成需要大量资源，例如 ? time: generally validation work is subject to rigorous time schedules; 时间：一般验证工作需要有一个严密的时间表 ? financial: validation often requires the time of specialized personnel and expensive technology. 资金：验证经常需要专业人员和昂贵的技术 ? human: validation requires the collaboration of experts from various disciplines (e.g. a multidisciplinary team, comprising quality assurance, engineering, information technology, manufacturin