ISPE指南目录

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
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。