参加一个培训时得到的一些关于蛋白药物生产工艺验证的资料，园内没有见过相同资料，发出来大家共享。
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cess validation of protein manufacturing.part1.rar (292.97k)
关于蛋白药物生产工艺验证的资料
cess validation of protein manufacturing.part2.rar (292.97k)
关于蛋白药物生产工艺验证的资料
cess validation of protein manufacturing.part3.rar (292.97k)
关于蛋白药物生产工艺验证的资料
cess validation of protein manufacturing.part4.rar (292.97k)
关于蛋白药物生产工艺验证的资料
cess validation of protein manufacturing.part5.rar (292.97k)
关于蛋白药物生产工艺验证的资料
cess validation of protein manufacturing.part6.rar (292.97k)
关于蛋白药物生产工艺验证的资料
cess validation of protein manufacturing.part7.rar (18.88k)
相当不错，十分有用。
辛苦了，耐心发完这么多。
很有用的，及时雨
感谢分享!
原来是PDA的技术报告－蛋白制造工艺验证(Technical Report No.42 - Process Validation of Protein Manufacturing)，这里有一份草稿：http://www.r0209.com/bbs/viewthread.php?tid=8488
PDA的技术报告目录
PDA——Parenteral Drug Association，注射用药物协会
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
(Please note: Technical Report No. 8 has been superseded by Technical Report No. 30 and is no longer available.)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 Tangential 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
更多见，不过都是要钱的 TR44刚颁布，之前为草案
！
分享！
分享a
积分限制取消，希望获得加分
cess validation of protein manufacturing.part1.rar (292.97k)
关于蛋白药物生产工艺验证的资料
cess validation of protein manufacturing.part2.rar (292.97k)
关于蛋白药物生产工艺验证的资料
cess validation of protein manufacturing.part3.rar (292.97k)
关于蛋白药物生产工艺验证的资料
cess validation of protein manufacturing.part4.rar (292.97k)
关于蛋白药物生产工艺验证的资料
cess validation of protein manufacturing.part5.rar (292.97k)
关于蛋白药物生产工艺验证的资料
cess validation of protein manufacturing.part6.rar (292.97k)
关于蛋白药物生产工艺验证的资料
cess validation of protein manufacturing.part7.rar (18.88k)
相当不错，十分有用。
辛苦了，耐心发完这么多。
很有用的，及时雨
感谢分享!
原来是PDA的技术报告－蛋白制造工艺验证(Technical Report No.42 - Process Validation of Protein Manufacturing)，这里有一份草稿：http://www.r0209.com/bbs/viewthread.php?tid=8488
PDA的技术报告目录
PDA——Parenteral Drug Association，注射用药物协会
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
(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 Tangential 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
更多见，不过都是要钱的 TR44刚颁布，之前为草案
！
分享！
分享a