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Technical Reports

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Technical Reports

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Technical Report No. 46 (Revised 2024) Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users

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Member price: $180.00 Nonmember price: $325.00
Technical Report No. 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages

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Member price: $0.00 Nonmember price: $0.00
Technical Report No. 73-2: Application of Medical Device Regulation Annex 1 Requirements for Staked Needle Syringes

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Member price: $180.00 Nonmember price: $325.00
Points to Consider No.9 Lessons Learned from the COVID-19 Pandemic

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Member price: $180.00 Nonmember price: $325.00
Points to Consider No.1 Aseptic Processing (Revised 2023)

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Member price: $180.00 Nonmember price: $325.00
Technical Report No. 91 Post-Approval Change Management

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Member price: $180.00 Nonmember price: $325.00

Standards

ANSI/PDA Standard 02-2021: Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing (single user digital version)

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Member 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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Member price: $180.00 Nonmember price: $325.00
ANSI/PDA Standard 04-2021: Phage Retention Nomenclature Rating for Small- and Large-Virus Retentive Filters (single user digital version)

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Member price: $180.00 Nonmember price: $325.00

Research

PDA Survey: Implementation of the New EU GMP Annex 1 and Implementation of Barrier Systems Survey

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PDA Survey: Availability of Single-Use-System Components and its Potential Impact on Product Supply Survey Results

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PDA Research: 2023 PDA Visual Inspection Survey (single user digital version)

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Member price: $180.00 Nonmember price: $325.00

Books

Global Sterile Manufacturing Regulatory Guidance Comparison & Assessment Tool Second Edition

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Member price: $325.00 Nonmember price: $350.00
GMP Validation: A Guide to International Regulatory Requirements

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Member price: $269.00 Nonmember price: $299.00
Industrial Pharmaceutical Microbiology Quality Control

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Member price: $269.00 Nonmember price: $299.00
Industrial Pharmaceutical Microbiology Standards & Controls 6th Edition

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Member price: $269.00 Nonmember price: $299.00
Conducting Compliant Investigations (single user digital version)

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Member price: $240.00 Nonmember price: $299.00
Quality by Design - An Indispensable Approach to Accelerate Biopharmaceutical Product Development (single user digital version)

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Member price: $240.00 Nonmember price: $299.00

PDA Letter

PDA Letter

PDA Journal

PDA Journal