ISPE GEP制药工程良好工程实践 (1).pdfVIP

ISPE Good Engineering Practice 国际制药工程协会 良好工程实践 胡士光 | 翻译 中国 北京 目录 3 Good Engineering Practice 良好工程实践 3 3.1 Core Concepts 核心概念 3 3.1.1 Risk Management 风险管理 3 3.1.2 Cost Management 成本管理 5 3.1.3 Organization and Control 组织和控制 8 3.2 Project Engineering 项目工程 10 3.2.1 Project Infrastructure 项目基础 10 3.2.2 Project Organization 项目组织 12 3.2.3 Value Analysis 价值分析 15 3.2.4 Planning and Monitoring 计划与监视 17 3.2.5 Design 设计 21 3.2.6 Design Reviews 设计审核 26 3.2.7 Construction 建造 29 3.2.8 Non-GxP Regulation Compliance 非 GxP 法规符合性 32 3.2.9 Commissioning and Qualification 调试与确认 34 3.2.10 Handover 移交 36 2 3 Good Engineering Practice 良好工程实践 3.1 Core Concepts 核心概念 3.1.1 Risk Management 风险管理 Risk management is at the core of most GEP activity such that there is a balanced evaluation of risks against benefits. Where practicable efforts should be made to design out or minimize identified risks to an acceptable level. 风险管理是大多数GEP活动的核心，以便对风险和收益进行平衡的 评估。应做出努力，设计出或将已识别的风险减至可接受的程度。 Sub-Practice 1: Identify 辨识 A regulated company should identify significant risks which may threaten its activities. 受监管的公司应识别可能威胁其活动的重大风险。 Sub-Practice 2:Evaluate 评价 Risks should be assessed using appropriate meth