Electronic PDA Technical Reports

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Book Thumbnail PDA Technical Report 1, Revised 2007, (TR 1) Validation of Moist Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control (single user digital version)

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Item Number: 43381


Book Thumbnail PDA Technical Report Distribution Series

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Item Number: 43498


Book Thumbnail PDA Technical Report No. 10, (TR 10) Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers (single user digital version)

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Item Number: 43215


Book Thumbnail PDA Technical Report No. 11, (TR 11) Sterilization of Parenterals by Gamma Radiation (single user digital version)

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Item Number: 43216


Book Thumbnail PDA Technical Report No. 12, (TR 12) Siliconization of Parenteral Drug Packaging Components (single user digital version)

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Item Number: 43217


Book Thumbnail PDA Technical Report No. 13 Revised, (TR 13) Fundamentals of an Environmental Monitoring Program (single user digital version)

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Item Number: 43513


Book Thumbnail PDA Technical Report No. 14, (TR 14) Validation of Column-Based Chromatography Processes for the Purification of Proteins (single user digital version)

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Item Number: 43220


Book Thumbnail PDA Technical Report No. 15, Revised 2009 (TR 15) Validation of Tangential Flow Filtration in Biopharmaceutical Applications (single user digital version)

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Item Number: 43221


Book Thumbnail PDA Technical Report No. 16, (TR 16) Effect of Gamma Irradiation on Elastomeric Closures (single user digital version)

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Item Number: 43222


Book Thumbnail PDA Technical Report No. 19, (TR 19) Rapid/Automated ID Methods Survey (single user digital version)

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Item Number: 43225


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Book Thumbnail PDA Technical Report No. 54-5 (TR 54-5) Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems (single user digital version)

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Item Number: 43533


Book Thumbnail PDA Technical Report No. 56 Revised 2016 (TR 56) Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance (API or Biological Active Substance) (single user digital version)

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Item Number: 43530


Book Thumbnail PDA Technical Report No. 60-2 (TR 60-2) Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage Forms (single user digital version)

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Item Number: 43532


Book Thumbnail PDA Technical Report No. 75 (TR 75) Consensus Method for Rating 0.1µm Mycoplasma Reduction Filters (single user digital version)

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Item Number: 43528


Book Thumbnail PDA Technical Report No. 76 (TR 76) Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (single user digital version)

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Item Number: 43529


Book Thumbnail PDA Technical Report No. 77 (TR 77) The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology (single user digital version)

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Item Number: 43531


Book Thumbnail Points to Consider for Aseptic Processing: Part 2, May 2016 (single user digital version)

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Item Number: 43527


Book Thumbnail PDA Technical Report No. 13 Revised, (TR 13) Fundamentals of an Environmental Monitoring Program (single user digital version)

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Item Number: 43513


Book Thumbnail PDA Technical Report No. 22, (TR 22) Revised 2011 Process Simulation for Aseptically Filled Products (single user digital version)

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Item Number: 43226


Book Thumbnail PDA Technical Report No. 26, (TR 26) Revised 2008, Sterilizing Filtration of Liquids (single user digital version)

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Item Number: 43230


Book Thumbnail PDA Technical Report No. 29, Revised 2012 (TR 29) Points to Consider for Cleaning Validation (single user digital version)

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Item Number: 43501


Book Thumbnail PDA Technical Report No. 43, Revised 2013 (TR 43) Identification and Classification of Nonconformities in Molded and Tubular Glass Containers for Pharmaceutical Manufacturing (single user digital version)

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Item Number: 43508


Book Thumbnail PDA Technical Report No. 56 Revised 2016 (TR 56) Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance (API or Biological Active Substance) (single user digital version)

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Item Number: 43530


Book Thumbnail PDA Technical Report No. 60 (TR 60) Process Validation: A Lifecycle Approach (single user digital version)

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Item Number: 43502


Book Thumbnail PDA Technical Report No. 70 (TR 70) Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities (single user digital version)

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Item Number: 43522


Book Thumbnail PDA Technical Report No. 76 (TR 76) Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging (single user digital version)

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Item Number: 43529


Book Thumbnail Points to Consider for Aseptic Processing: Part 2, May 2016 (single user digital version)

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Item Number: 43527


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