ISPE指南目录

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

·         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

·         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