Electronic PDA Technical Reports

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Book Thumbnail PDA Technical Information Bulletin 2, Generic Test Procedures for Elastomeric Closures (single user digital version) - 30% Off

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Item Number: 42129


Book Thumbnail PDA Technical Information Bulletin 4, Aspects of Container/Closure Integrity (single user digital version) - 30% Off

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Item Number: 43204


Book Thumbnail PDA Technical Methods Bulletin 1, Extractables from Elastomeric Closures: Analytical Procedures for Functional Group Characterization/Identification (single user digital version) - 30% Off

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Item Number: 43205


Book Thumbnail PDA Technical Methods Bulletin 2, Elastomeric Closures: Evaluation of Significant Performance and Identity Characteristics (single user digital version) - 30% Off

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Item Number: 43206


Book Thumbnail PDA Technical Methods Bulletin 3, Glass Containers for Small Volume Parenteral Products: Factors for Selection and Test Methods for Identification (single user digital version) - 30% Off

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Item Number: 43207


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


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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. 74 (TR 74) Reprocessing of Biopharmaceuticals (single user digital version)

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Item Number: 43526


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. 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. 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. 65, (TR 65) Technology Transfer (single user digital version)

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Item Number: 43514


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 1, January 2015 (single user digital version)

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Item Number: 43520


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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