GAMP?Good Practice Guides

? GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems ? GAMP 5: 保证GXP计算机系统符合性的基于风险的方法

? A Risk-Based Approach to Calibration Management (Second Edition) ? 基于风险的校正管理方法（第二版）

? A Risk-Based Approach to Electronic Records and Signatures ? 基于风险的电子记录和签名方法

? A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)

? 基于风险的GXP符合性实验室计算机化系统方法（第二版）

? A Risk-Based Approach to GxP Process Control Systems (Second Edition) ? 基于风险的GXP工艺控制体系方法（第二版）

? A Risk-Based Approach to Operation of GxP Computerized Systems - A Companion Volume to GAMP 5

? 基于风险的GXP计算机系统操作方法---GAMP 5姊妹篇 ? A Risk-Based Approach to Regulated Mobile Applications ? 基于风险的移动APP管理方法

? A Risk-Based Approach to Testing of GxP Systems (Second Edition) ? 基于风险的GXP系统检测方法（第二版） ? Electronic Data Archiving ? 电子数据归档

? Global Information Systems Control and Compliance ? 全球信息系统控制和符合性

? IT Infrastructure Control and Compliance ? IT基础设施控制和符合性 ? Legacy Systems ? 遗留系统

? Manufacturing Execution Systems – A Strategic and Program Management Approach

? 生产执行系统—策略和编程管理方法

? GAMP Good Practice Guides Under Development ? 制订中的GAMP GPG

ISPE Baseline? Pharmaceutical Engineering Guides for New and Renovated Facilities

ISPE基准：新设施和创新型设施药品工程指南

? Volume 1: Active Pharmaceutical Ingredients (Second Edition) - Revision to Bulk Pharmaceutical Chemicals

? 卷1：活性药物成分（第二版）---对散装药用化学品的修订 ? Volume 2: Oral Solid Dosage Forms (Second Edition) ? 卷2：口服固体制剂（第二版）

? Volume 3: Sterile Product Manufacturing Facilities (Second Edition)

? 卷3：无菌药品生产设施（第二版）

? Volume 4: Water and Steam Systems (Second Edition) ? 卷4：水和蒸汽系统（第二版）

? Volume 5: Commissioning and Qualification ? 卷5：调试和确认

? Volume 6: Biopharmaceutical Manufacturing Facilities (Second Edition) ? 卷6：生物药品生产设施（第二版）

? Volume 7: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP) ? 卷7：基于风险的药品生产（风险MAPP） ? Baseline Guides Under Development ? 制订中的基准指南

ISPE Guides

? ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment

? ISPE指南：基于风险的设施、系统和设备传送科学方法

? ISPE Guide: Biopharmaceutical Process Development and Manufacturing ? ISPE指南：生物药品工艺开发和生产（新出版） ? ISPE Guides Under Development ? 在制订中的ISPE指南

ISPE Good Practice Guides 优良规范指南

? ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification

? ISPE GPG：在调试和确认中应用风险管理

? ISPE Good Practice Guide: Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems (Second Edition)

? ISPE GPG：药用水和蒸汽系统调试和确认方法（第二版）（新出） ? ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition) ? ISPE GPG：制药设备颗粒密闭性能的评估（第二版） ? ISPE Good Practice Guide: Booklet Labels ? ISPE GPG：书册标签

? ISPE Good Practice Guide: Clinical Supply Systems ? ISPE GPG：临床补给系统（新出）

? ISPE Good Practice Guide: Cold Chain Management ? ISPE GPG：冷链管理

? ISPE Good Practice Guide: Comparator Management ? ISPE GPG：对照组管理

? ISPE Good Practice Guide: Development of Investigational Therapeutic Biological Products

? ISPE GPG：临床前治疗用生物产品开发

? ISPE Good Practice Guide: Good Engineering Practice

? ISPE GPG：优良工程规范

? ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products (NIMPs) ? ISPE GPG：协调非临床前药品的定义和使用

? ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning (HVAC) ? ISPE GPG：HVAC

? ISPE Good Practice Guide: Interactive Response Technology ? ISPE GPG：互动反馈技术

? ISPE Good Practice Guide: Maintenance ? ISPE GPG：维护

? ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water System

? ISPE GPG：制药用水系统的臭氧消毒

? ISPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities ? ISPE GPG：包装、贴标和仓储设计 ? ISPE Good Practice Guide: Process Gases ? ISPE GPG：工艺用气

? ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry

? ISPE GPG：制药行业的项目管理

? ISPE Good Practice Guide: Quality Laboratory Facilities ? ISPE GPG：质量化验室设施

? ISPE Good Practice Guide: Technology Transfer (Second Edition) ? ISPE GPG：技术转移（第二版）（新出） ? ISPE Good Practice Guides Under Development ? 制订中的ISPE GPG

PQLI? Guides 药品质量生命周期实施指南

? PQLI Overview Good Practice Guide ? PQLI概览GPG

? Product Quality Lifecycle Implementation (PQLI) from Concept to Continual

Improvement

Part 1: Product Realization using QbD, Concepts and Principles

? 从概念到持续改进的药品质量生命周期实施（PQLI）第一部分：利用质量源于设计（QbD）实现实现，概念和原则

? Product Quality Lifecycle Implementation (PQLI) from Concept to Continual

Improvement

Part 2: Product Realization using QbD, Illustrative Example

? 从概念到持续改进的药品质量生命周期实施（PQLI）第二部分：利用质量源于设计（QbD）实现实现，实例解说

? Product Quality Lifecycle Implementation (PQLI) from Concept to Continual

Improvement

Part 3: Change Management System as a Key Element of a Pharmaceutical Quality System

? 从概念到持续改进的药品质量生命周期实施（PQLI）第三部分：药品质量体系关键要素变更管理

? Product Quality Lifecycle Implementation (PQLI) from Concept to Continual

Improvement

Part 4: Process Performance and Product Quality Monitoring System (PP&PQMS)

? 从概念到持续改进的药品质量生命周期实施（PQLI）第四部分：工艺性能和药品质量监测体系（PP&PQMS）

? ISPE PQLI Guides Under Development ? 制订中的ISPE PQLI指南