《制药工业的CGMP文件体系》.pdfVIP

Document System 文件管理系统 制药工业的CGMP文件体系 2008 1 FDA’s Unwritten Rule FDA 没有文件规定的”法规” If something is not documented, it either does not exist or never took place. 如果做的工作没有文件纪录，那么这些做 的工作是会被认为不存在的或者是从来没 有发生过的。 2 Documentation is very Important 文件的重要性 Documentation is the key to operating a pharmaceutical company in compliance with GMP requirements. The system of documentation devised or adopted should have as its main objective to establish, monitor, and record quality for all aspects of the production and quality control. 文件体系是制药工业达到GMP要求的重要手段。文件 体系的主要目的是建立，跟踪，记录生产和质量控制的 所有与质量有关的因素。 3 Documentation Type 制药工业中常用的文件种类 Descriptive Documents 描述性文件 SOPs, Protocols 计划, Specifications 质量标准, 等 等 Forms for Recording Data 数据纪录表格 Lab data record forms 实验表格, batch records 批记录, 等等 Identification Numbers 识别标记编号 SOP 号码, equipment numbers 设备号码, form numbers 表格号码, 等等 Labels 标志 quarantine 待检, release 放行, reject 不合格标签 (Detailed discussion in the following slides) 4 1. Descriptive Documents 描述性文件 Provide instructions on how to perform a procedure or a study, or give a description of specifications, they are: 指导如何实施一项程序或研究，或描述质量标准 a. Standard operating procedures (SOP) 标准操作规程 b. Protocols (for validation studies, stability studies, safety studies) 验证计划，稳定性研究计划，安全性研究计划 c. Master production and control record (Master formulae) 生产主记录，控制记录 d. Specifications 质量标准