ISPE指南目录(最新整理)

ISPE 指南按系列分类的目录清单：

GAMP? 5

•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

GAMP? Good Practice Guides

• 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

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