GAMP®Good Practice Guides
∙ GAMP 5: A Risk-Bad 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-Bad Approach to Calibration Management (Second Edition)
∙ 基于风险的校正管理方法（第二版）
∙ A Risk-Bad Approach to Electronic Records and Signatures
∙ 基于风险的电子记录和签名方法
∙ A Risk-Bad 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-Bad 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-Bad 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-Bad Approach to Regulated Mobile Applications
∙ 基于风险的移动APP管理方法
∙ A Risk-Bad 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
数字口译∙反应的 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 Baline? Pharmaceutical Engineering Guides for New and Renovated Facilities
一千年以后歌词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）三心二意的近义词
∙ Volume 3: Sterile Product Manufacturing Facilities (Second Edition)
∙飞机模型的英文 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）
大运河的作用∙ 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-Bad Manufacture of Pharmaceutical Products (Risk-MaPP)
∙ 卷7：基于风险的药品生产（风险MAPP）
∙ Baline Guides Under Development
∙ 制订中的基准指南
ISPE Guides
∙ ISPE Guide: Science and Risk-Bad 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）
车祸赔偿协议书∙ ISPE Good Practice Guide: Asssing 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 U of Non-Investigational Medicinal Products (NIMPs)
白菜猪肉饺子馅的做法
∙ 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 Respon 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
