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PDA Catalog of Technical Documents
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Technical Reports
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Points to Consider No. 12: Restricted Access Barrier Systems
PDF Single UserMember price: $180.00 Nonmember price: $325.00 -
Points to Consider No. 11: Development, Classification, Manufacture, Control, and Testing of Plasmids and Vectors Used in ATMP Production
PDF Single UserMember price: $180.00 Nonmember price: $325.00 -
Technical Report No. 46 (Revised 2024) Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users
PDF Single UserMember price: $180.00 Nonmember price: $325.00 -
Technical Report No. 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages
PDF Single UserMember price: $0.00 Nonmember price: $0.00 -
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
PDF Single UserMember price: $180.00 Nonmember price: $325.00
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Standards
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PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools
PDF Single userMember price: $180.00 Nonmember price: $325.00 -
PDA/ANSI Standard 03-2025: Standard Practice for Quality Risk Management of Aseptic Processes
PDF Single userMember price: $180.00 Nonmember price: $325.00 -
ANSI/PDA Standard 02-2021: Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing
PDF Single userMember price: $180.00 Nonmember price: $325.00
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Research
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PDA Survey: 2025 Transportation Validation Benchmarking Survey
PDF Single userMember price: $180.00 Nonmember price: $325.00 -
PDA Survey: 2024 PDA Annex 1: One Year into Implementation Survey
PDF Single userMember price: $180.00 Nonmember price: $325.00 -
PDA Survey: Implementation of the New EU GMP Annex 1 and Implementation of Barrier Systems Survey
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Books
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Pharmaceutical Regulatory Inspections (3rd Edition)
PDF Single UserMember price: $269.00 Nonmember price: $299.00 -
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Quality Risk Management: A Practical Guide
PDF Single UserMember price: $230.00 Nonmember price: $255.00 -
Global Sterile Manufacturing Regulatory Guidance Comparison & Assessment Tool Second Edition
PDF Single UserMember price: $325.00 Nonmember price: $350.00 -
GMP Validation: A Guide to International Regulatory Requirements
PDF Single UserMember price: $269.00 Nonmember price: $299.00 -
Industrial Pharmaceutical Microbiology Quality Control
PDF Single UserMember price: $269.00 Nonmember price: $299.00
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