ISPE指南目录(最新整理)

1、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

2、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 vol

3、ume 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

4、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 gpgispe baseline? pharmaceutical engineering guides for new and renovated facil

5、itiesispe 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

6、：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

7、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 guid

8、es 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 ed

9、ition) 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

10、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 practi

11、ce 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 technolo

12、gy 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

13、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

14、 development 制订中的 ispe gpgpqli? 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 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

15、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 ma

16、nagement 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 improvementpart 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

17、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“”“”at the end, xiao bian gives you a passage. minand once said, people who learn to learn are very happy people. in every wonderful life, learning is an eternal theme. as a professional clerical and teaching position, i understand the importance of continuous learning, life is diligent, nothing can be gained, only continuous learning can achieve better self. only by constantly learning and mastering the latest relevant know