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PDA技术报告清单（官网2015年更新）
2015-05-22
PDA技术报告清单
1 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2007
3 Validation of Dry Heat Processes Used for Depyrogenation and Sterilization Revised 2013 (Published 1981) 01003 43506
4 Design Concepts for the Validation of Water-for-Injection Systems 1983
5 Sterile Pharmaceutical Packaging: Compatibility and Stability 1984
7 Depyrogenation 1985
9 Review of Commercially Available Particulate Measurement Systems 1988
10 Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers 1988
11 Sterilization of Parenterals by Gamma Radiation 1988
12 Siliconization of Parenteral Drug Packaging Components 1988
13 Fundamentals of an Environmental Monitoring Program Revised 2014 (Published 1990)
14 Validation of Column-Based Chromatography Processes for the Purification of Proteins Revised 2008 (Published 1992)
15 Validation of Tangential Flow Filtration in Biopharmaceutical Applications Revised 2009 (Published 1992)
16 Effect of Gamma Irradiation on Elastomeric Closures 1992
17 Current Practices in the Validation of Aseptic Processing -- 1992 1993
18 Report on the Validation of Computer-Related Systems 1995
19 Rapid/Automated ID Methods Survey 1990
20 Report on Survey of Current Industry Gowning Practices 1990
21 Bioburden Recovery Validation 1990
22 Process Simulation for Aseptically Filled Products Revised 2011(Published 1996)
23 Industry Survey on Current Sterile Filtration Practices 1996
24 Current Practices in the Validation of Aseptic Processing – 1996 1996
25 Blend Uniformity Analysis: Validation and In-Process Testing 1997
26 Sterilizing Filtration of Liquids Revised 2008 (Published 1998)
27 Pharmaceutical Package Integrity 1998
28 Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals Revised 2006 (Published 1998)
29 Points to Consider for Cleaning Validation Revised 2012 (Published 1998)
30 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2012
31 Validation and Qualification of Computerized Laboratory Data Acquisition Systems 1999
32 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2004
33 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2013
34 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，2001
35 A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry 2001
36 Current Practices in the Validation of Aseptic Processing – 2001 2002
38 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，2006
39 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，2007
40 Sterilization Filtration of Gases 2005
41 Virus Filtration 2008
42 Process Validation of Protein Manufacturing 2005
43 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2013
44 Quality Risk Management for Aseptic Processes 2008
45 Filtration of Liquids Using Cellulose-Based Depth Filters 2008
46 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，2009
47 Preparation of Virus Spikes Used for Virus Clearance Studies 2010
48 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，2010
49 Points to Consider for Biotechnology Cleaning Validation 2010
50 Alternative Methods for Mycoplasma Testing 2010
51 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，2010
52 Guidance Good Distribution Practices for the Pharmaceutical Supply Chain 2011
53 Guidance for Industry: Stability Testing to Support Distribution of New Drug Products 2011
54 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，2012
54-2 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，2013
54-3 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，2013
54-4 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，2013
55 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，2012
56 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，2012
57 Analytical Method Validation and Transfer for Biotechnology Products 2012
58 Risk Management for Temperature-Controlled Distribution 2012
59 Utilization of Statistical Methods for Production Monitoring 2012
60 Process Validation: A Lifecycle Approach 2013
61 Steam In Place 2013
62 Recommended Practices for Manual Aseptic Processes 2013
63 Quality Requirements for the Extemporaneous Preparation of Clinical Trial 2013
64 Active Temperature-Controlled Systems: Qualification Guidance 2013
65 Technology Transfer 2014
66 Application of Single-Use Systems in Pharmaceutical Manufacturing 2014
67 Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and Cosmetics 2014 非无菌药物、医疗器械和化妆品中致病菌排除，2014
68 Risk-Based Approach for Prevention and Management of Drug Shortages 2014
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