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PDA Catalog of Technical Documents
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Technical Reports
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NEW
Points to Consider No. 15: Mobile Manufacturing
PDF Single UserMember price: $180.00 Nonmember price: $325.00 -
NEW
Points to Consider No. 14: Manufacturing of ATMPs – Facility Design (Part 1)
PDF Single UserMember price: $180.00 Nonmember price: $325.00 -
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Technical Report No. 26 (Revised 2025): Sterilizing Filtration of Liquids
PDF Single UserMember price: $180.00 Nonmember price: $325.00 -
NEW
Manufacturing Technology Guide No.1: Aseptic Filling, Engineering, and Operation
PDF Single UserMember price: $180.00 Nonmember price: $325.00 -
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Technical Report No. 22 (Revised 2025): Process Simulation for Aseptically Filled Products
PDF Single UserMember price: $180.00 Nonmember price: $325.00 -
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Points to Consider No. 13: Materials in ATMP Manufacturing
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: $135.00 Nonmember price: $243.75
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Research
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PDA Survey: 2025 PUPSIT Benchmarking Survey
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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
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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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