PDA——Parenteral Drug Association，注射用药物协会（www.pda/）
PDA技术报告目录／railPDA Publications
hm怎么读● 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 Identificationchubby bunny
hfg● Technical Information Bulletin No.新纪元英语
2 - Generic Test Procedures for Elastomeric Closures
4 - Aspects of Container/Closure Integrity
● Technical Report No.
1 Validation of Moist Heat Sterilization Process: Cycle Design, Development, Qualification and Ongoing Control, Revid 2007 (original Technical Monograph No. 1, Validation of Steam Sterilization Cycles, first published in 1978)
Technical Monograph No. 2 - Validation of Aptic Filling for Solution Drug Product, 1980 (replaced by Technical Report No. 22 and is no longer available.)
3 Validation of Dry Heat Process ud 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 Aptic Drug Powder Filling Process, 1984 (replaced by Technical Report No. 22 and is no longer available.)初中英语语法视频
德语学习培训班7 Depyrogenation, 1985
8 Parametric Relea of Parenteral Solutions Sterilized by Moist Heat Sterilization,
1987 (Plea note: Technical Report No. 8 has been superded 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 (Revid 2001)
14 Validation of Column-Bad Chromatography Process for the Purification of Proteins, Revid 2008 (original name: Industry Perspective on the Validation of Column-Bad Separation Process for the Purification of Proteins, first published in 19
92)
15 Industry Perspective on Validation of Tangential Flow Filtration in Bio-pharmaceutical Application, 1992 (Revid 2009)
16 Effect of Gamma Irradiation on Elastomeric Closures, 1992
17 Current Practices in the Validation of Aptic Processing - 1992, 1993
18 PDA Report on the Validation of Computer Related Systems, 1995
钚的读音19 Rapid/Automated ID Methods Survey, 1990
20 Report on Survey of Current Industry Gowning Practices, 1990
中学生如何学好英语21 Bioburden Recovery Validation, 1990
san22 Process Simulation Testing for Aptically Filled Products, 1996
23 Industry Survey on Current Sterile Filtration Practices, 1996
24 Current Practices in the Validation of Aptic Processing - 1996, 1996
25 Blend Uniformity Analysis: Validation and In-Process Testin, 1997
26 Sterilizing Filtration of Liquids, 1998 (Revid 2008)
27 Pharmaceutical Package Integrity, 1998
28 Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals, 1998 (revid 2006)
29 Points to consider for Cleaning Validation, 1998
30 Parametric Relea 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 (revid 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 Propod Training Model for the Microbiological Function in the Pharmaceutical Industry, 2001
36 Current Practices in the Validation of Aptic 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, revid 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)
