blueski推荐 [2015/10/7]




·         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


·         Volume 1: Active Pharmaceutical Ingredients (Second Edition) - Revision to Bulk Pharmaceutical Chemicals

·         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)

·         2:口服固体制剂(第二版)

·         Volume 3: Sterile Product Manufacturing Facilities (Second Edition)

·         3:无菌药品生产设施(第二版)

·         Volume 4: Water and Steam Systems (Second Edition)

·         4:水和蒸汽系统(第二版)

·         Volume 5: Commissioning and Qualification

·         5:调试和确认

·         Volume 6: Biopharmaceutical Manufacturing Facilities (Second Edition)

·         6:生物药品生产设施(第二版)

·         Volume 7: Risk-Based Manufacture of Pharmaceutical Products (Risk-MaPP)

·         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 GPGHVAC

·         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