ISPE指南目录.doc

ISPE指南按系列分类的目录清单：GAMP?5GAMP 5:A Risk-Based Approach to Compliant GxP Computerized SystemsGAMP 5:保证GXP计算机系统符合性的基于风险的方法GAMP?Good Practice GuidesA 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 ComplianceIT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 GPGISPE Baseline?Pharmaceutical Engineering Guides for New and Renovated FacilitiesISPE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 GuidesISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and EquipmentISPE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 ManufacturingISPE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 QualificationISPE 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 LabelsISPE GPG：书册标签ISPE Good Practice Guide: Clinical Supply SystemsISPE GPG：临床补给系统（新出）ISPE Good Practice Guide: Cold Chain ManagementISPE GPG：冷链管理ISPE Good Practice Guide: Comparator ManagementISPE GPG：对照组管理ISPE Good Practice Guide: Development of Investigational Therapeutic Biological ProductsISPE GPG：临床前治疗用生物产品开发ISPE Good Practice Guide: Good Engineering PracticeISPE 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：HVACISPE Good Practice Guide: Interactive Response TechnologyISPE GPG：互动反馈技术ISPE Good Practice Guide: MaintenanceISPE GPG：维护ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water SystemISPE GPG：制药用水系统的臭氧消毒ISPE Good Practice Guide: Packaging, Labeling, and Warehousing FacilitiesISPE GPG：包装、贴标和仓储设计ISPE Good Practice Guide: Process GasesISPE GPG：工艺用气ISPE Good Practice Guide: Project Management for the Pharmaceutical IndustryISPE GPG：制药行业的项目管理ISPE Good Practice Guide: Quality Laboratory FacilitiesISPE 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 GPGPQLI?Guides 药品质量生命周期实施指南PQLI Overview Good Practice GuidePQLI概览GPGProduct Quality Lifecycle Implementation (PQLI) from Concept to Continual ImprovementPart 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 ImprovementPart 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 ImprovementPart 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