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标题: ISPE指南目录（2015-5-4官网发布） [打印本页]

作者: 一场梦 时间: 2015-5-5 11:10 PM
标题: ISPE指南目录（2015-5-4官网发布）

ISPE指南目录（2015-5-4官网发布）

2015-05-04

以下为ISPE指南按系列分类的目录清单。

GAMP? 5

· GAMP 5: A Risk-BasedApproach 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 PracticeGuides

· A Risk-Based Approach to Calibration Management (SecondEdition)

· 基于风险的校正管理方法（第二版）

· A Risk-Based Approach to Electronic Records andSignatures

· 基于风险的电子记录和签名方法

· A Risk-Based Approach to GxP Compliant LaboratoryComputerized 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 ComputerizedSystems - 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 (SecondEdition)

· 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 ProgramManagement 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? PharmaceuticalEngineering 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 (SecondEdition) - 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）

· Volume7: 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 theDelivery 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 andManufacturing

· 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 forCommissioning and Qualification

· ISPE GPG：在调试和确认中应用风险管理

· ISPE Good Practice Guide: Approaches to Commissioning andQualification 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 ParticulateContainment 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 InvestigationalTherapeutic 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 andUse 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 AirConditioning (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 ofPharmaceutical Water System

· ISPE GPG：制药用水系统的臭氧消毒

· ISPE Good Practice Guide: Packaging, Labeling, andWarehousing 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 thePharmaceutical 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 (SecondEdition)

· 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) fromConcept to Continual Improvement
Part 1: Product Realization usingQbD, 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) fromConcept to Continual Improvement
Part 2: Product Realization usingQbD, 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) fromConcept to Continual Improvement
Part 3: Change Management System as aKey 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) fromConcept to Continual Improvement
Part 4: Process Performance andProduct 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

Last Update: 10 October 2014

来源：http://zhuyujiao1972.blog.163.com/blog/static/98694727201544101348490/

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