Electronic PDA Technical Reports

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Book Thumbnail PDA Technical Report Distribution Series

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Item Number: 43498


Book Thumbnail PDA Technical Report No. 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 No. 3, Revised 2013 (TR 3) Validation of Dry Heat Processes Used for Depyrogenation and Sterilization (single user digital version)

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Item Number: 43506


Book Thumbnail PDA Technical Report No. 5, (TR 5) Sterile Pharmaceutical Packaging: Compatibility and Stability (single user digital version)

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Item Number: 43210


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


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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. 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 Aging Facilities (single user digital version)

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Item Number: 43534


Book Thumbnail PDA Technical Report No. 1, Revised 2007, (TR 1) Validation of Moist Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control (single user digital version)

Member Price: $150.00
Nonmember Price: $325.00
Gov. Price: $150.00
Your Price: $325.00
Item Number: 43381


Book Thumbnail PDA Technical Report No. 3, Revised 2013 (TR 3) Validation of Dry Heat Processes Used for Depyrogenation and Sterilization (single user digital version)

Member Price: $150.00
Nonmember Price: $325.00
Gov. Price: $150.00
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Item Number: 43506


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

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Nonmember Price: $325.00
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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. 48 (TR 48) Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance (single user digital version)

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Item Number: 43487


Book Thumbnail PDA Technical Report No. 49 (TR 49) Points to Consider for Biotechnology Cleaning Validation (single user digital version)

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Item Number: 43488


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)

Member Price: $150.00
Nonmember Price: $325.00
Gov. Price: $150.00
Your Price: $325.00
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)

Member Price: $150.00
Nonmember Price: $325.00
Gov. Price: $150.00
Your Price: $325.00
Item Number: 43530


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