pda技术报告目录

PDA的技术报告目录
PDA——Parenteral Drug Association，注射用药物协会（/）
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
Technical Methods Bulletin No.2 - Elastomeric Closures: Evaluation of Significant Performance and Identity Characteristics
Technical Methods Bulletin No.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 Technical Information Bulletin No.4 - Aspects of Container/Closure Integrity
Technical Report No.1 - Validation of Steam Sterilisation Cycles
Technical Report No.3 - Validation of Dry Heat Processes used for Sterilisation and Depyrogenation
Technical Report No.4 - Design Concepts for the Validation of a Water for Injection System Technical Report No.5 - Sterile Pharmaceutical Packaging: Compatibility and Stability Technical Report No.7 - Depyrogenation
Technical Report No.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of Parenteral Solutions Sterilized by Moist Heat Sterilization, 1987 (Please note: Technical Report No. 8 has been superseded by Technical Report No. 30 and is no longer available.)
Technical Report No.9 - Review of Commercially Available Particulate Measurement Systems Technical Report No.10 - Parenteral Formulations of Proteins & Peptides: Stability and Stabilizers Technical Report No.11 - Sterilization of Parenterals by Gamma Radiation
Technical Report No.12 - Siliconization of Parenteral Drug Packaging Components
Technical Report No.13 - Fundamentals of a Microbiological Environmental Monitoring Program Technical Report No.14 - Industry Perspective on the Validation of Column-Based Separation Processes for the Purification of Proteins
Technical Report No.15 - Industry Perspective on Validation of T angential Flow Filtration in Bio-pharmaceutical Application
Technical Report No.16 - Effect of Gamma Irradiation on Elastomeric Closures
Technical Report No.17 - Current Practices in the Validation of Aseptic Processing ? 1992 Technical Report No.18 - PDA Report on the Validation of Computer Related Systems Technical Report No.19 - Rapid/Automated ID Methods Survey
Technical Report No.20 - Report on Survey of Current Industry Gowning Practices
Technical Report No.21 - Bioburden Recovery Validation
Technical Report No.22 - Process Simulation Testing for Aseptically Filled Products
Technical Report No.23 - Industry Survey on Current Sterile Filtration Practices
Technical Report No.24 - Current Practices in the Validation of Aseptic Processing 1996 Technical Report No.25 - Blend Uniformity Analysis: Validation and In-Process Testing Technical Report No.26 - Sterilizing Filtration of Liquids
Technical Report No.27 - Pharmaceutical Package Integrity
Technical Report No.28 - Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals Technical Report No.29 - Points to consider for Cleaning Validation
Technical Report No.30 - Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat
Technical Report No.31 - Validation & Qualification of Computerized Laboratory Data Acquisition Systems
Technical Report No.32 - Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations
Technical Report No.33 - Evaluation, Validation & Implementation of New Microbiological Testing Methods
Technical Report No.34 - Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products
Technical Report No.35 - A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry
Technical Report No.36 - Current Practices in the Validation of Aseptic Processing - 2001 Technical Report No.39 - Cold Chain Guidance for Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products Through the Transportation Environment
Technical Report No.40 - Sterilizing Filtration of Gases
Technical Report No.41 - Virus Filtration
Technical Report No.42 - Process Validation of Protein Manufacturing
Technical Report No.43 - Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing
Technical Report No.44 - Quality Risk Management for Aseptic Processes
Technical Report No.45 - Filtration of Liquids Using Cellulose-Based Depth Filters, 2008。