PDA技术报告总目录（官网更新）

3 . 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 2013

4 . Design Concepts for the Validation of Water-for-Injection Systems 1983 注射用水系统验证的设计概念， 1983

5 . Sterile Pharmaceutical Packaging: Compatibility and Stability 1984  无菌制剂包装：相容性和稳定性， 1984

7. Depyrogenation 1985  除热源， 1985

9. Review of Commercially Available Particulate Measurement Systems 1988 商业可采购的颗粒物检测系统审核， 1988

10. 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， 1988

11. Sterilization of Parenterals by Gamma Radiation 1988  静脉注射伽马辐射灭菌， 1988

12. Siliconization of Parenteral Drug Packaging Components 1988  静脉注射剂药品包装组分硅化处理， 1988

13. Fundamentals of an Environmental Monitoring Program Revised 2014 (Published 1990)   环境监测计划原则，修订 2014

14. 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 2008

15. 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 2009

16. Effect of Gamma Irradiation on Elastomeric Closures 1992  人造橡胶塞伽马辐射效应， 1992

17. Current Practices in the Validation of Aseptic Processing -- 1992 1993  无菌工艺验证现行规范， 1992 ， 1993

18. Report on the Validation of Computer-Related Systems 1995  计算机相关系统验证报告， 1995

19. Rapid/Automated ID Methods Survey 1990  快速 / 自动 ID 方法调查， 1990

20. Report on Survey of Current Industry Gowning Practices 1990  行业现行更衣规范调查报告， 1990

21. Bioburden Recovery Validation 1990  生物负载回收率验证， 1990

22. Process Simulation for Aseptically Filled Products Revised 2011 (Published 1996)  无菌药品模拟工艺灌装，修订 2011

23. Industry Survey on Current Sterile Filtration Practices 1996  现行无菌过滤实践行业调查， 1996

24. Current Practices in the Validation of Aseptic Processing – 1996 1996  无菌工艺验证现行规范， 1996

25. Blend Uniformity Analysis: Validation and In-Process Testing 1997  混合均一性分析：验证和中控测试， 1997

26. Sterilizing Filtration of Liquids Revised 2008 (Published 1998)  液体无菌过滤，修订 2008

27. Pharmaceutical Package Integrity 1998 药品包装完整性， 1998

28. Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals Revised 2006 (Published 1998) 无菌 API 模拟工艺灌装，修订 2006

29. Points to Consider for Cleaning Validation Revised 2012 (Published 1998)  清洁验证的考虑要点，修订 2012

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  计算机化实验室数据获取系统验证和确认， 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 制药行业微生物功能培训模式建议， 2001

36. Current Practices in the Validation of Aseptic Processing – 2001 2002  无菌工艺验证现行规范 --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  气体的无菌过滤， 2005

41. Virus Filtration 2008  病毒过滤， 2008

42. Process Validation of Protein Manufacturing 2005  蛋白质生产的工艺验证， 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  无菌工艺的质量风险管理， 2008

45. 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， 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  用于病毒清除研究的病毒加标样制备， 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  生物制品清洁验证考虑要点， 2010

50. Alternative Methods for Mycoplasma Testing 2010  支原体测试替代性方法， 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  药品供应链优良销售规范指南， 2011

53. 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， 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  生物制品的分析方法验证和转移， 2012

58. Risk Management for Temperature-Controlled Distribution 2012  温度受控销售风险管理， 2012

59. Utilization of Statistical Methods for Production Monitoring 2012  生产监测用统计学方法使用， 2012

60. Process Validation: A Lifecycle Approach 2013  工艺验证：生命周期方法， 2013

61. Steam In Place 2013  在线蒸汽， 2013

62. Recommended Practices for Manual Aseptic Processes 2013 人工无菌工艺规范建议， 2013

63. Quality Requirements for the Extemporaneous Preparation of Clinical Trial 2013  临床试验临时制备药物的质量要求， 2013

64. Active Temperature-Controlled Systems: Qualification Guidance 2013  在用温度控制系统：确认指南， 2013

65. Technology Transfer 2014  技术转移， 2014

66. Application of Single-Use Systems in Pharmaceutical Manufacturing 2014  药物生产中单次使用系统的应用， 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  基于风险的药品存贮预防和管理， 2014

69.  Technical Report No. 69 (TR 69) Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations  制药生产操作中的生物负载与生物膜

70. PDA Technical Report No. 70 (TR 70) Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities 无菌生产设施的清洁与消毒基本原理

71. Technical Report No. 71, Emerging Methods for Virus Detection  病毒检测新方法

72. Technical Report No. 72, Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance  全球销售控温药品的防热保护系统  ：确认与操作指南

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