PDA Bookstore
Technical Reports
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Technical Report No. 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages
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Technical Report No. 73-2: Application of Medical Device Regulation Annex 1 Requirements for Staked Needle Syringes
PDF Single UserMember price: $180.00 Nonmember price: $325.00 -
Points to Consider No.9 Lessons Learned from the COVID-19 Pandemic
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Points to Consider No.1 Aseptic Processing (Revised 2023)
PDF Single UserMember price: $180.00 Nonmember price: $325.00 -
Technical Report No. 91 Post-Approval Change Management
PDF Single UserMember price: $180.00 Nonmember price: $325.00 -
Technical Report No. 43 (Revised 2023): Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing
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 (single user digital version)
PDF Single userMember price: $180.00 Nonmember price: $325.00 -
ANSI/PDA Standard 05-2021: Consensus Method for Rating Filters for Mycoplasma Reduction (single user digital version)
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ANSI/PDA Standard 04-2021: Phage Retention Nomenclature Rating for Small- and Large-Virus Retentive Filters (single user digital version)
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Research
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PDA Research: 2023 PDA Visual Inspection Survey (single user digital version)
PDF Single UserMember price: $180.00 Nonmember price: $325.00 -
PDA Research: 2021 PDA Aseptic Processing Simulation Survey (Single user digital version)
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PDA Research: 2020 Particulate Matter in Flexible Containers Survey (single user digital version)
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Books
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Industrial Pharmaceutical Microbiology Quality Control
PDF Single UserMember price: $269.00 Nonmember price: $299.00 -
Industrial Pharmaceutical Microbiology Standards & Controls 6th Edition
PDF Single UserMember price: $269.00 Nonmember price: $299.00 -
Conducting Compliant Investigations (single user digital version)
PDF Single userMember price: $240.00 Nonmember price: $299.00 -
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
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