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PDA Technical Report No. 52 (TR 52) Guidance for Good Distribution Practices (GDPs) For the Pharmaceutical Supply Chain (single user digital version)
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This technical report describes the overall quality system for distribution of pharmaceutical products and is meant to assist manufacturers in assuring that quality, integrity, and efficacy of the product are not compromised in the distribution channels, including handling, storage, transportation and … -
PDA Technical Information Bulletin 2, Generic Test Procedures for Elastomeric Closures (single user digital version)
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As a result of a CGMP requirement that the parenteral manufacturer confirm supplier certification on packaging components, PDA Research Committee Task Group No. 14 developed test procedures that may be helpful in establishing the identity of elastomeric closure formulations.Clearance Sale 30% Off!Original … -
PDA Technical Report No. 20, (TR 20) Report on Survey of Current Industry Gowning Practices (single user digital version)
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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.A survey of selected member companies of the PDA was taken by the Gowning Task Force to determine gowning practices within … -
PDA Technical Report No. 36, (TR 36) Current Practices in the Validation of Aseptic Processing - 2001 (single user digital version)
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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.The validation of aseptic processing continues to be a major area of interest within the pharmaceutical industry. Five years … -
PDA Technical Report No. 35, (TR 35) A Proposed Training Model for the Microbiological Function in the Pharmaceutical Industry (single user digital version)
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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.Many firms today have separate departments with different training requirements. Employees associated with the Microbiological … -
PDA Technical Report No. 34, (TR 34) Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products (single user digital version)
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This Technical Report was prepared by PDA Isolation Technology Task Force Members.The report addresses essential user requirements for the application of isolator technology to a broad range of manufacturing, development and testing applications in the health care product manufacturing industry. It covers … -
PDA Technical Report No. 32, Revised, (TR 32) Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations (single user digital version)
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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This current revision to the technical report by the PDA Industry Advisory Board (IAB) reflects the lessons learned in four … -
PDA Technical Report No. 31, (TR 31) Validation and Qualification of Computerized Laboratory Data Acquisition Systems (single user digital version)
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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only. This Technical report was prepared by the PhRMA CSVWG and PDA Computer Related Systems … -
PDA Technical Report No. 30 Revised 2012, (TR 30) Parametric Release of Pharmaceuticals and Medical Device Products Terminally Sterilized by Moist Heat (single user digital version)
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PDA Technical Report No. 30 (Revised 2012): Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat provides current demonstrated best practices of this sterile product release method with an emphasis on use of science-based approaches during the development of a parametric release … -
PDA Technical Report No. 28 Revised, (TR 28) Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals (single user digital version)
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This Technical Report was prepared by the Joint PDA/PhRMA Sterile Bulk Pharmaceutical Chemicals Task Force. This document provides guidance relative to the validation of aseptic processing activities utilized for the production of sterile bulk pharmaceutical chemicals. It draws upon the concepts … -
PDA Technical Report No. 27, (TR 27) Pharmaceutical Package Integrity (single user digital version)
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This Technical Report was prepared by PDA Task Force on Container/Closure Integrity. This report reviews issues of pharmaceutical product package integrity and provides guidance for evaluating the barrier qualities of a pharmaceutical package. It supersedes the previously issued PDA Technical Information … -
PDA Technical Report No. 26, (TR 26) Revised 2008, Sterilizing Filtration of Liquids (single user digital version)
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This Technical Report was prepared by members of the PDA Sterilizing Filtration of Liquids Task Force. PDA’s original Technical Report No. 26, published in 1998 described the use and validation of sterilizing filtration to a generation of pharmaceutical scientists and engineers. This revision was … -
PDA Technical Report No. 25, (TR 25) Blend Uniformity Analysis: Validation and In-Process Testing (single user digital version)
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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This report was written to clarify the significant regulatory and technological issues impacting validation approaches and … -
PDA Technical Report No. 24, (TR 24) Current Practices in the Validation of Aseptic Processing - 1996 (single user digital version)
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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This Technical Report was prepared by Dr. James Agalloco and Dr. James Akers. This survey updates PDA 1992 aseptic processing … -
PDA Technical Report No. 23, (TR 23) Industry Survey on Current Sterile Filtration Practices
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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This Technical Report was prepared by the PDA Sterile Filtration Committee. This document contains the results of the July … -
PDA Technical Report No. 22, (TR 22) Revised 2011 Process Simulation for Aseptically Filled Products
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Technical Report No. 22 (Revised 2011), Process Simulation for Aseptically Filled Products, originally published in 1996. The Task Force charged with updating the document ensured that the new version reflects the continuing changes that have occurred in aseptic processing technology within the global … -
PDA Technical Report No. 19, (TR 19) Rapid/Automated ID Methods Survey
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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This survey conducted by PDA Microbial ID Task Force summarizes microbial identification practices within the pharmaceutical … -
PDA Technical Report No. 17, (TR 17) Current Practices in the Validation of Aseptic Processing - 1992
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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This Technical Report was prepared by Dr. James Agalloco and Dr. James Akers.It contains the results of a 1992 PDA survey … -
PDA Technical Report No. 16, (TR 16) Effect of Gamma Irradiation on Elastomeric Closures
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Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.This Technical Report was prepared by A Parenteral Drug Association Task Force.The report examines the effects of gamma irradiation … -
PDA Technical Report No. 15, Revised 2009 (TR 15) Validation of Tangential Flow Filtration in Biopharmaceutical Applications
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This Technical Report was prepared by members of the PDA Validation of Tangential Flow Filtration in Biopharmaceutical Applications Task Force. PDA Technical Report No. 15 (Revised 2009): Validation of Tangential Flow Filtration in Biopharmaceutical Applications, updates the 1992 original version …
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