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蒲公英制药技术论坛原创作品 1.0 Introduction 前言 1.1 Purpose and Scope 目的和范围 This Technical Report (TR) is intended to provide practical guidance on the implementation of a lifecycle approach to pharmaceutical process validation (PV). It contains information that enables manufacturers to implement globally-compliant PV programs consistent with the principles of recent lifecycle-based PV guidance documents and current expectations for Pharmaceutical Quality Systems (1-4). In pharmaceutical manufacturing, ―process validation‖ is the collection and evaluation of data -from the process design stage through commercial production that establishes scientific evidence that a process is capable of consistently delivering quality product (3). The U.S. FDA and EMA consider PV a requirement in both general and specific terms in current Good Manufacturing Practice (cGMP) guidelines and an essential element in the assurance of drug quality (2,3,5). 技术报告（Technical Report,TR ）旨在为制药工艺验证（PV ）生命周期方法的实施提供实用指南。 它包含的信息能够使生产厂家实施全球认可的工艺验证程序，该程序与最近的基于生命周期的工艺 验证指导文件和现行对药品质量系统期望相一致（1-4 ）。在医药生产中，―工艺验证‖是收集和评价 工艺设计阶段的数据，通过商业化生产的方式确定科学的证据，证明一个工艺能够持地提供高质量 的产品（3 ）。美国FDA 和欧洲药监局认定PV 在现行GMP 指南的综述和具体条框中都是必要条件 和药品质量保证的必需元素（2,3,5 ）。 The PV lifecycle concept links product and process development, the qualification of the commercial manufacturing processes, and maintenance of the commercial production process in a coordinated effort (3). When based on sound process understanding and used with quality risk management principle s, the lifecycle approach allows manufacturers to use continuous process verification (enhanced approach) in addition to, or instead of, traditional PV (1,2,6). 工艺验证生命周期概念连接产品和工艺开发、商业化生产确认和协同努力下商业化生产过程的维持 （3 ）。当基于良好的工艺理解和使用质量风险管理时，生命周期法可考虑生产者在使用传统的工艺 验证外，再使用连续工艺验证（增强的方式），或者直接由后者代