PDA技术报告清单2015.docx

PDA技术报告清单（官网2015年更新）/ProductCatalog/ProductCategory.aspx?ID=301. Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control Revised 2007 (Published 1980)湿热灭菌工艺验证：循环设计、研发、确认和持续控制，修订20073. Validation of Dry Heat Processes Used for Depyrogenation and Sterilization Revised 2013 (Published 1981) 01003 43506用于除热源和灭菌的干热工艺验证，修订20134. Design Concepts for the Validation of Water-for-Injection Systems 1983注射用水系统验证的设计概念，19835. Sterile Pharmaceutical Packaging: Compatibility and Stability 1984无菌制剂包装：相容性和稳定性，19847. Depyrogenation 1985 除热源，19859. Review of Commercially Available Particulate Measurement Systems 1988商业可采购的颗粒物检测系统审核，198810. Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers 1988 蛋白质和多肽注射制剂：稳定性和稳定剂，198811.Sterilization of Parenterals by Gamma Radiation 1988 静脉注射伽马辐射灭菌，198812. Siliconization of Parenteral Drug Packaging Components 1988 静脉注射剂药品包装组分硅化处理，198813.Fundamentals of an Environmental Monitoring Program Revised 2014 (Published 1990) 环境监测计划原则，修订201414. Validation of Column-Based Chromatography Processes for the Purification of Proteins Revised 2008 (Published 1992) 蛋白纯化用柱色谱工艺验证，修订200815. Validation of Tangential Flow Filtration in Biopharmaceutical Applications Revised 2009 (Published 1992) 生物制药用正切流过滤验证，修订200916. Effect of Gamma Irradiation on Elastomeric Closures 1992 人造橡胶塞伽马辐射效应，199217. Current Practices in the Validation of Aseptic Processing - 1992 1993 无菌工艺验证现行规范，1992，199318. Report on the Validation of Computer-Related Systems 1995 计算机相关系统验证报告，199519.Rapid/Automated ID Methods Survey 1990快速/自动ID方法调查，199020. Report on Survey of Current Industry Gowning Practices 1990 行业现行更衣规范调查报告，199021. Bioburden Recovery Validation 1990 生物负载回收率验证，199022. Process Simulation for Aseptically Filled Products Revised 2011 (Published 1996) 无菌灌装药品工艺模拟，修订201123. Industry Survey on Current Sterile Filtration Practices 1996 现行无菌过滤实践行业调查，199624. Current Practices in the Validation of Aseptic Processing 1996 1996 无菌工艺验证现行规范，199625. Blend Uniformity Analysis: Validation and In-Process Testing 1997 混合均一性分析：验证和中控测试，199726. Sterilizing Filtration of Liquids Revised 2008 (Published 1998) 液体无菌过滤，修订200827. Pharmaceutical Package Integrity 1998 药品包装完整性，199828. Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals Revised 2006 (Published 1998) 无菌散装药用化学物工艺模拟测试，修订200629. Points to Consider for Cleaning Validation Revised 2012 (Published 1998) 清洁验证的考虑要点，修订201230. Parametric Release of Pharmaceuticals and Medical Device Products Terminally Sterilized by Moist Heat Revised 2012 (Published 1999) 最终湿热灭菌的药物和医疗器械参数放行，修订201231. Validation and Qualification of Computerized Laboratory Data Acquisition Systems 1999 计算机化实验室数据获取系统验证和确认，199932. Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations Revised 2004 (Published 1999)提供受法规管理的药物操作用计算机产品和服务的供应商审计，修订200433. Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods Revised 2013 (Published 2000) 替代性和快速微生物方法的评估、验证和实施，修订201334. Design and Validation of Isolate Systems for the Manufacturing and Testing of Health Care Products 2001 保健药品的生产和检测分离系统的设计和验证，200135. A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry 2001 制药行业微生物功能培训模式建议，200136. Current Practices in the Validation of Aseptic Processing 2001 2002 无菌工艺验证的现行规范-2001，200238. Manufacturing Chromatography Systems Post-Approval Changes: (ChromPAC):Chemistry, Manufacturing and Controls Documentation 2006 批准后生产用色谱系统：研发、生产和控制文件，200639. Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment 2007 温度受控药物指南：通过运输环境来维护对温度敏感的药物的质量，200740. Sterilization Filtration of Gases 2005 气体的无菌过滤，200541. Virus Filtration 2008 病毒过滤，200842. Process Validation of Protein Manufacturing 2005 蛋白质生产的工艺验证，200543. Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing Revised 2013 (Published 2007) 药物生产用模型制备和管式玻璃容器的识别和分类，修订201344. Quality Risk Management for Aseptic Processes 2008 无菌工艺的质量风险管理，200845. Filtration of Liquids Using Cellulose-Based Depth Filters 2008 使用纤维素基础深层过滤器的液体过滤，200846. Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User 2009最终里程：给最终用户的药物优良销售规范指南，200947. Preparation of Virus Spikes Used for Virus Clearance Studies 2010 用于病毒清除研究的病毒加标样制备，201048. Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance 2010 湿热灭菌系统：设计、调试、运行、确认和维护，201049. Points to Consider for Biotechnology Cleaning Validation 2010 生物制品清洁验证考虑要点，201050. Alternative Methods for Mycoplasma Testing 2010 支原体测试替代性方法，201051. Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use 2010气体和蒸汽相除污染工艺生物指示剂：质量标准、生产、控制和使用，201052. Guidance Good Distribution Practices for the Pharmaceutical Supply Chain 2011 药品供应链优良销售规范指南，201153.Guidance for Industry: Stability Testing to Support Distribution of New Drug Products 2011 行业指南：支持新药销售的稳定性测试，201154. Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations 2012药品和生物制品生产操作的质量风险管理实施，201254-2. Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operation: Annex 1: Case Study Examples for Quality Risk Management in Packaging and Labeling 2013 药品和生物制品生产操作的质量风险管理实施，附录1：包装和标识中的质量风险管理案例研究，201354-3. Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations Annex 2: Case Studies in the Manufacturing of Pharmaceutical Drug Products 2013药品和生物制品生产操作的质量风险管理实施，附录2：药品生产中的质量风险管理案例研究，201354-4. Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations Annex 3: Case Studies in the Manufacturing of Biotechnological Bulk Drug Substances 2015 药品和生物制品生产操作的质量风险管理实施，附录3：生物散装药用物质生产中的质量风险管理案例研究，201355. Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole Taints and Odors in the Pharmaceutical and Consumer Healthcare Industries 2012 药物和保健行业中2，4，6-三溴苯甲醚和2，4，6-三氯苯甲醚污染和气味的检测和移除，201256. Application of Phase-Appropriate Quality Systems and CGMP to the Development of Therapeutic Protein Drug Substance 2012 治疗用蛋白质药用物质研发中与阶段相适当的质量体系和CGMP应用，201257. Analytical Method Validation and Transfer for Biotechnology Products 2012生物制品的分析方法验证和转移，201258. Risk Management for Temperature-Controlled Distribution 2012 温度受控销售风险管理，201259. Utilization of Statistical Methods for Production Monitoring 2012 生产监测用统计学方法使用，2