PDA技术报告目录

PDA——Parenteral Drug Association，注射用药物协会（http://www.pda.org/）

PDA技术报告目录／PDA Publications

● Technical Methods Bulletin No.

1 - Extractables from Elastomeric Closures: Analytical Procedures for Functional Group Characterization/Identification

2 - Elastomeric Closures: Evaluation of Significant Performance and Identity Characteristics

3 - Glass Containers for Small Volume Parenteral Products: Factors for Selection and Test Methods for Identification

● Technical Information Bulletin No.

2 - Generic Test Procedures for Elastomeric Closures 4 - Aspects of Container/Closure Integrity

● Technical Report No.

1 Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control, Revised 2007 (original Technical Monograph No. 1, Validation of Steam Sterilization Cycles, first published in 1978)

Technical Monograph No. 2 - Validation of Aseptic Filling for Solution Drug Product, 1980 (replaced by Technical Report No. 22 and is no longer available.)

3 Validation of Dry Heat Processes used for Sterilisation and Depyrogenation, 1981

4 Design Concepts for the Validation of a Water for Injection System, 1983

5 Sterile Pharmaceutical Packaging: Compatibility and Stability, 1984

6 Validation of Aseptic Drug Powder Filling Processes, 1984 (replaced by Technical Report No. 22 and is no longer available.) 7 Depyrogenation, 1985

8 Parametric Release of Parenteral Solutions Sterilized by Moist Heat Sterilization,

1987 (Please note: Technical Report No. 8 has been superseded by Technical Report No. 30 and is no longer available.)

9 Review of Commercially Available Particulate Measurement Systems, 1988

10 Parenteral Formulations of Proteins & Peptides: Stability and Stabilizers, 1988

11 Sterilization of Parenterals by Gamma Radiation, 1988

12 Siliconization of Parenteral Drug Packaging Components, 1988 13 Fundamentals of a Microbiological Environmental Monitoring Program, 1990 (Revised 2001)

14 Validation of Column-Based Chromatography Processes for the Purification of Proteins, Revised 2008 (original name: Industry Perspective on the Validation of Column-Based Separation

Processes for the Purification of Proteins, first published in 1992) 15 Industry Perspective on Validation of Tangential Flow

Filtration in Bio-pharmaceutical Application, 1992 (Revised 2009) 16 Effect of Gamma Irradiation on Elastomeric Closures, 1992

17 Current Practices in the Validation of Aseptic Processing - 1992, 1993

18 PDA 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 Testing for Aseptically Filled Products, 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 Testin, 1997

26 Sterilizing Filtration of Liquids, 1998 (Revised 2008) 27 Pharmaceutical Package Integrity, 1998

28 Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals, 1998 (revised 2006)

29 Points to consider for Cleaning Validation, 1998

30 Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat, 1999

31 Validation & Qualification of Computerized Laboratory Data Acquisition Systems, 1999

32 Auditing of Suppliers Providing Computer Products and

Services for Regulated Pharmaceutical Operations, 1999 (revised 2004)

33 Evaluation, Validation & Implementation of New Microbiological Testing Methods, 2000

34 Design and Validation of Isolator Systems for the

Manufacturing and Testing of Health Care Products, 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

39 Guidance for Temperature-Controlled Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment, revised 2007 (orginal name: Cold Chain Guidance for Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal

Products Through the Transportation Environment, first published in 2005)

40 Sterilizing Filtration of Gases, 2005 41 Virus Filtration, 2005 (revised 2008)

42 Process Validation of Protein Manufacturing, 2005

43 Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing, 2007

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, 2010

47 Preparation of Virus Spikes Used for Virus Clearance Studies, 2010

48 Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance, 2010

PDA的技术报告目录/刊物 技术方法

第1号-萃取物从弹性封路措施：分析程序功能群表征/鉴定 2 弹性封路措施：对重要的性能和身份特征评价

3 小容量注射用玻璃容器：选择和试验方法因素的识别 技术信息通报

1 蒸汽灭菌周期验证

2 对弹性封通用测试程序

3 验证流程，干热灭菌和除热源使用 4 为一个注射水系统验证设计概念 5 无菌医药包装：兼容性和稳定性 6

7 除热源

8 肠外参数解湿热灭菌消毒释放 1987年（注意：技术报告已被第8号第30号技术报告取代，不再可用） 9 审查颗粒测量系统投放市场

10 注射制剂的蛋白质及肽：稳定性和稳定剂 11 由伽马辐射肠道灭菌 12 肠外药品包装成分渗Si

13 一个微生物环境监测方案基础

14 行业对基于列的分离工艺验证的角度来看，用于蛋白质的分离纯化

15 关于切向流过滤验证产业视角在生物医药中应用 16 γ-辐射对弹性封

17 当前实践中的无菌工艺验证？ 1992年 18 掌上报告计算机相关系统验证 19 快速/自动调查ID方法

20 对当前行业调查报告gowning 实践 21 生物负载恢复验证

22 无菌填充过程的仿真测试产品 23 关于当前产业调查无菌过滤实验 24 当前实践中的无菌工艺验证 1996年 25 混合均匀度分析：验证和流程测试 26 液体过滤杀菌

27 医药软件包的完整性

28 过程无菌原料药化工仿真测试 29 点考虑清洗验证

30 药品参数放行末由湿热灭菌

31 计算机实验室验证及数据采集系统的鉴定

32 中医药部分提供受规管电脑产品及服务供应商审核 33 评估，验证和测试新方法的实施微生物 34 设计及制造及保健品的隔振系统验证测试 35 微生物的作用，为拟议的培训模式在制药行业 36 现行做法是无菌生产过程的验证 2001 37 38

39 对药品冷链指导：维护交通环境，通过对温度敏感的药品产品质量

40 气体过滤杀菌 41 病毒过滤

42 蛋白质制造工艺验证

43 识别及铸模，管状玻璃容器不符合药品生产的分类 44 质量风险管理过程的无菌

45 利用纤维素为基层的深层过滤液体 2008年过滤

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