PDA Bookstore
PDA Catalog of Technical Documents
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Technical Reports
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Technical Report No. 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry
PDF Single userMember price: $180.00 Nonmember price: $325.00 -
Technical Report No. 39 (Revised 2021): Guidance for Temperature-Controlled Medicinal Products - Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment
PDF Single userMember price: $180.00 Nonmember price: $325.00 -
Technical Report No. 87: Current Best Practices for Pharmaceutical Glass Vial Handling and Processing
PDF Single userMember price: $180.00 Nonmember price: $325.00 -
Points to Consider in Remote and Hybrid GMP/GDP Inspections
PDF Single userMember price: $180.00 Nonmember price: $325.00 -
Technical Report No. 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing
PDF Single userMember price: $180.00 Nonmember price: $325.00 -
PDA Technical Report No. 85 (TR 85) Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers (single user digital version)
PDF Single userMember price: $180.00 Nonmember price: $325.00
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Standards
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ANSI/PDA Standard 02-2021: Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing
PDF Single userMember price: $135.00 Nonmember price: $243.75 -
ANSI/PDA Standard 05-2021: Consensus Method for Rating Filters for Mycoplasma Reduction
PDF Single userMember price: $180.00 Nonmember price: $325.00 -
ANSI/PDA Standard 04-2021: Phage Retention Nomenclature Rating for Small- and Large-Virus Retentive Filters
PDF Single userMember price: $180.00 Nonmember price: $325.00
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Research
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PDA Research: 2020 Particulate Matter in Flexible Containers Survey (single user digital version)
PDF Single userMember price: $180.00 Nonmember price: $325.00 -
PDA Research: 2021 Post-Approval Change Issues and Impacts Survey (single user digital version)
PDF Single userMember price: $180.00 Nonmember price: $325.00 -
PDA Research: 2019 PDA Traceability of Primary Packaging Survey (single user digital version)
PDF Single userMember price: $180.00 Nonmember price: $325.00
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Books
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Quality by Design - An Indispensable Approach to Accelerate Biopharmaceutical Product Development (single user digital version)
PDF Single userMember price: $240.00 Nonmember price: $299.00 -
Cleanroom Contamination Prevention & Control: A Practical Guide to the Science (single user digital version)
PDF Single userMember price: $240.00 Nonmember price: $299.00 -
Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers, Volume 2: Digital Data, Insights, Metrics and Analytics (single user digital version)
PDF Single userMember price: $200.00 Nonmember price: $249.00 -
Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers, Volume 1: Digital Technologies for Automation and Process Improvement (single user digital version)
PDF Single userMember price: $200.00 Nonmember price: $249.00 -
Water Activity Applications in the Pharmaceutical Industry (single user digital version)
PDF Single userMember price: $175.00 Nonmember price: $220.00
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