ISPE指南目录

1、ISPE指南按系列分类的U录清单:GAMP，5GAMP 5: A Risk-Based Approach to Compliant GxP Computerized SystemsGxAMP 5:保证GXP计算机系统符台性的基于风险的方法GAMP? Good Practice GuidesA RiskE“sud Approach co Calibracioii Managcrnciir （Second Edirion）墓于风险的校正管理方法（第二版）A RiskEnsud Approach to Electronic Records and Sigtiacurcs墓于风险的电于记录和签乞方法A

2、 RiskE“sud Approach to CtxP Compliant Laboratorr Computerized Systems （Second Edition）基于风险的GXP符台性实验室计算机化系统方法（第二版）A RiskE“sed Approach to CtxP Process Control Systems （Second Edi noil）基于风险的GXP I*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墓于风险

3、的GXP计算机系统操作方法GAMP 5姊妹篇A RiskE“sed Approach co Regulated Mobile Applications荃于风险的移动APP管理方法A RiskE“sud Approach co Testing of CrxP Systems （Second Edition）墓于风险的GXP系统检测方法（第二版）Electronic Data Archiving电于数据归档Global Informarion Systems Control and Compliance全球信恳系统控制和符合性IT Infrasrrucmrc Control and Complia

4、nceIT基础设施控制和符合性Legacy Systems遗留系统Manufacturing Execution Systems 一 A Strategic and Progiam Management Approach 生产执行系统一策站和编程管理方法GAMP G）（k1 Practice Guides Under Development制订中的gamp gpgISPE Baseline Pharmaceutical Enginccring 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: Activ

5、e Pharmaceutical liigrcdicncs （Second Edirion） Revision co Bulk Pharmaccuucal 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 Produce Nlaiiufaccuring Facilities （Second Edirion） 卷3:无菌药品生产设施（第二版）Volume 4: Water and Secam Systems （S

6、econd E&ci（）n）卷4:水和蕉汽系统（第二版）Volume 5: Commissioning and Qualification卷5:调试和确认Volume 6: Biopharmaccurical Maiiufacruring Facilirics （Second Edition） 卷6：生物药品生产设施（第二版）Volume 7: Risk-Based Manufacture of Pharmaccucical Pnxluccs （Risk-MaPP）卷7:墓于风险的药品生产（风险MAPP）Baseline Guides Under Dclopmciic制订中的基准指南ISPE

7、GuidesSPE Guide： Science and Risk-Based Approach for the Dclivcrx- of Facilities, Syscems, and EquipmentISPE指南：基于风险的设施、系统和设备传送科学方法1SPE Guide: Biopharmaccurical Process Ocvclopmcnt and ManufacuiringISPE指南：生物药品工艺开險和生产（新出版）1SPE Guides Under Dcvclopmcnc在制订中的SPE指南ISPE Good Practice Guides 优良规范指南1SPE Good

8、 Practice Guide: Applied Risk Management for Commissioning and Qualificacion1SPEGPG:在调试和确认中应用风险管理ISPE Good Pracricc Guide： Approaches to Comtnissioning and Qualification ofPharmaccurical Water and Steam Systems （Second 巳di cion）1SPEGPG:药用水和蒸汽系统调试和确认方法（第二版）（新出）SPE Good Pracricc Guide: Assessing the P

9、arriculatc Containment Performance ofPharmaccurical Equipment （Second Edirion）JSPEGPG:制药设备颗粒密闭性能的评估（第二版）SPE Good Practice Guide： Booklet Labels1SPEGPG:韦册标签ISPE Good Pracricc Guide: Clinical Supply Systems1SPEGPG:临床补给系统（新出）ISPE Good Pracricc Guide: Cold Chain MaiiagcmcncISPE GPG:冷链管理1SPE Good Practic

10、e Guide： Comparator ManagementISPEGPG:对照组管理SPE Good Practice Guide: Development of Investigational Therapeutic Biological Products1SPEGPG:临床前治疔用生物产品开支IS卩巳 Good Practice Guide： God Engineering Practice1SPEGPG:优良工程规范1SPE Good Practice Guide: Harmonizing the Dcfiiiiuon and Use of Non-lnvcsrigauonal Med

11、icinal Produces (NIMPs)ISPEGPG:协调非临床前药品的定义和使用1SPE Good Practice Guide: Hearing, Vcnularion, and Air Condirioning (HVAC) 1SPEGPG: HVAC1SPE Good Practice Guide: Intcracuvc Response Technology-1SPE GPG:互动反馈技术1SPE Good Practice Guide: Maintcilailcc1SPEGPG: f隹护SPE Good Practice Guide: Ozone Sailiuzarion

12、of Pharmaccuucal Water Svstem 1SPEGPG:制药用水系统的臭氧消毒SPE Good Practice Guide: Packaging, Labeling, and Warehousing Facilities 1SPEGPG:包装、贴标和仓储设计SPE Good Practice Guide: Process Gases1SPEGPG:工艺用气1SPE Good Practice Guide: Project Management for the Pharmaceutical Industry-1SPEGPG:制药行业的项目管浬1SPE Good Practi

13、ce Guide: Quality Laboratonrr Facilities1SPEGPG:质量化验室设施SPE Good Practice Guide: Tuchnology Transfer (Second Edition)1SPEGPG:技术转移(第二版)(新出)1SPE Good Practice Guides Under Development制订中的1SPE GPGPQLI? Guides药品质量生命周期实施指南PQL1 Ovemew G(x)d Practice GuidePQL1 概览 GPGProduct Quality Lifecycle Implcmcntarioii

14、 (PQL1) from Concept co Conrinual ImprovementParc 1: Ptcxluct Realization using QbD、Concepts and Principles从槪念到持续改进的药品质量生命周期实施(PQLJ)第一部分：利用质量源于 设计(QbD)实现实现，槪念和原则Product Quality- Lifecycle Implcmcntarioii (PQL1) from Concept co Continual ImprovementParc 2: Prcxluct Realization using QbD, Illustrative

15、 Example从槪念到持渎改进的药品质量生命周期实施(PQU)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 (PQL1) from Concept co Coilrinual Improvement卩久代 3: Change Management System as a Key Element of a Pharmaceutical Quality System 从槪念到持续改进的药品质量生命周期实施(卩QL】)第三部分：药品质量体系 关犍要素变更管理Product Quality Lifecycle