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Publications

technical reports standards surveys books
Technical Report No. 26 (Revised 2025): Sterilizing Filtration of Liquids NEW
Manufacturing Technology Guide No.1: Aseptic Filling, Engineering, and Operation NEW
Technical Report No. 22 (Revised 2025): Process Simulation for Aseptically Filled Products NEW
Points to Consider No. 13: Materials in ATMP Manufacturing NEW
Points to Consider No. 12: Restricted Access Barrier Systems
Points to Consider No. 11: Development, Classification, Manufacture, Control, and Testing of Plasmids and Vectors Used in ATMP Production​
Technical Report No. 46 (Revised 2024) Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users
Technical Report No. 68 (Revised 2024): Risk-Based Approach for Prevention and Management of Drug Shortages
Technical Report No. 73-2: Application of Medical Device Regulation Annex 1 Requirements for Staked Needle Syringes
Points to Consider No.9 Lessons Learned from the COVID-19 Pandemic
Points to Consider No.1 Aseptic Processing (Revised 2023)
Technical Report No. 91 Post-Approval Change Management
Technical Report No. 43 (Revised 2023): Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing
Technical Report No. 90: Contamination Control Strategy Development
Technical Report No. 89: Strategies for Vaccine Development
Points to Consider for Microbial Control in ATMP Manufacturing
Technical Report No.41 (Revised 2022): Virus Filtration
Technical Report No. 65 (Revised 2022): Technology Transfer
Points to Consider in Remote and Hybrid GMP/GDP Audits
Technical Report No. 13 (Revised 2022): Fundamentals of an Environmental Monitoring Program
Technical Report No. 88: Microbial Data Deviation Investigations in the Pharmaceutical Industry
Technical Report No. 39 (Revised 2021): Guidance for Temperature-Controlled Medicinal Products - Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment
Technical Report No. 87: Current Best Practices for Pharmaceutical Glass Vial Handling and Processing
Points to Consider in Remote and Hybrid GMP/GDP Inspections
Technical Report No. 86: Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing
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)
Technical Report No. 60-3: Process Validation: A Lifecycle Approach, Annex 2: Biopharmaceutical Drug Substances Manufacturing
Reporte Tecnico No. 1 (Revisado en 2007) Validacion de los Procesos de Esterilizacion por Calor Humedo: Diseno del Ciclo, Desarrollo, Calificacion y Control Continuo
Technical Report No. 13-2: Fundamentals of an Environmental Monitoring Program Annex 1: Environmental Monitoring of Facilities Manufacturing Low Bioburden Products
Technical Report No. 84: Integrating Data Integrity Requirements into Manufacturing & Packaging Operations
Points to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing (PUPSIT)
Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration
Points to Consider for Sensitivity to Oxidation by Peroxide
Points to Consider for the Aseptic Processing of Sterile Pharmaceutical Products in Isolators
Technical Report No. 54-6: Formalized Risk Assessment for Excipients
Technical Report No. 83: Virus Contamination in Biomanufacturing: Risk Mitigation, Preparedness, and Response
PDA Reporte Tecnico No. 13 (Revisado): Fundamentos de un Programa de Monitoreo Ambiental en Español
Technical Report No. 82: Low Endotoxin Recovery
Technical Report No. 81: Cell-Based Therapy Control Strategy
Technical Report No. 80: Data Integrity Management System for Pharmaceutical Laboratories
Technical Report No. 79: Particulate Matter Control in Difficult to Inspect Parenterals
Technical Report No. 78: Particulate Matter in Oral Dosage Forms
Points to Consider for Aging Facilities
Technical Report No. 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems
Technical Report No. 60-2 Process Validation: A Lifecycle Approach, Annex 1: Oral Solid Dosage/Semisolid Dosage Forms
Technical Report No. 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology
Technical Report No. 56 (Revised 2016): Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance
Technical Report No. 76: Identification and Classification of Visible Nonconformities in Elastomeric Components and Aluminum Seals for Parenteral Packaging
Technical Report No. 75: Consensus Method for Rating 0.1μm Mycoplasma Reduction Filters
Technical Report No. 74: Reprocessing of Biopharmaceuticals
Technical Report No. 73: Prefilled Syringe User Requirements for Biotechnology Applications
Technical Report No. 72: Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance
Technical Report No. 71: Emerging Methods for Virus Detection
Technical Report No. 70: Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities
Technical Report No. 69: Bioburden and Biofilm Management in Pharmaceutical Manufacturing Operations
Technical Report No. 57-2: Analytical Method Development and Qualification for Biotechnology Products
Technical Report No. 54-4: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations: Annex 3: Case Studies in the Mfg of Biotechnological Bulk Drug Substances
Technical Report No. 67: Exclusion of Objectionable Microorganisms from Nonsterile Pharmaceuticals, Medical Devices, and Cosmetics
Technical Report No. 66: Application of Single-Use Systems in Pharmaceutical Manufacturing
PDA Technical Series: Sterilization — Compilation of Technical Reports and Journal Articles on Pharmaceutical Sterilization (single user digital version)
Technical Report No. 54-3: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations:Annex 2: Case Studies in the Manufacturing of Pharmaceutical Drug Products
Technical Report No. 33 (Revised 2013): Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods
Technical Report No. 64: Active Temperature-Controlled Systems: Qualification Guidance
Technical Report No. 63: Quality Requirements for the Extemporaneous Preparation of Clinical Trial Materials
Technical Report No.3 (Revised 2013): Validation of Dry Heat Processes Used for Depyrogenation and Sterilization
Technical Report No. 62: Recommended Practices for Manual Aseptic Processes
Technical Report No. 54-2: Implementation of Quality Risk Management for Pharmaceutical & Biotechnology Manufacturing Operation:Annex 1: Case Study Examples for Quality Risk Management in Packaging & Labeling
Technical Report No. 61: Steam In Place
Technical Report No. 60: Process Validation: A Lifecycle Approach
Technical Report No. 29, Revised 2012: Points to Consider for Cleaning Validation
Technical Report No. 59: Utilization of Statistical Methods for Production Monitoring
Technical Report No. 58: Risk Management for Temperature-Controlled Distribution
Technical Report No. 57: Analytical Method Validation and Transfer for Biotechnology Products
Technical Report No. 55: Detection and Mitigation of 2,4,6-Tribromoanisole and 2,4,6-Trichloroanisole Taints and Odors in the Pharmaceutical and Consumer Healthcare Industries
Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations
Technical Report No. 44: Quality Risk Management for Aseptic Processes
Technical Report No.1 (Revised 2007): Validation of Moist Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control
Technical Report No. 45: Filtration of Liquids Using Cellulose-Based Depth Filters
Technical Report No. 49: Points to Consider for Biotechnology Cleaning Validation
Technical Report No. 48: Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance
Technical Report No. 51: Biological Indicators for Gas and Vapor-Phase Decontamination Processes: Specification, Manufacture, Control and Use
Technical Report No. 50: Alternative Methods for Mycoplasma Testing
Technical Report No. 47 (TR 47): Preparation of Virus Spikes Used for Virus Clearance Studies
Technical Report No. 53: Guidance for Industry: Stability Testing to Support Distribution of New Drug Products
Technical Report No. 52: Guidance for Good Distribution Practices (GDPs) For the Pharmaceutical Supply Chain
PDA Technical Report No. 34: Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products
Technical Report No. 30 Revised 2012: Parametric Release of Pharmaceuticals and Medical Device Products Terminally Sterilized by Moist Heat
Technical Report No. 28 Revised: Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals
Technical Report No. 27: Pharmaceutical Package Integrity
Technical Report No. 15, Revised 2009: Validation of Tangential Flow Filtration in Biopharmaceutical Applications
Technical Report No. 14: Validation of Column-Based Chromatography Processes for the Purification of Proteins
Technical Report No. 12: Siliconization of Parenteral Drug Packaging Components
Technical Report No. 38: Manufacturing Chromatography Systems Postapproval Changes (ChromPAC): Chemistry, Manufacturing and Controls Documentation
Technical Report No. 40: Sterilizing Filtration of Gases
PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools
PDA/ANSI Standard 03-2025: Standard Practice for Quality Risk Management of Aseptic Processes
ANSI/PDA Standard 02-2021: Cryopreservation of Cells for Use in Cell Therapies, Gene Therapies, and Regenerative Medicine Manufacturing
ANSI/PDA Standard 05-2021: Consensus Method for Rating Filters for Mycoplasma Reduction
ANSI/PDA Standard 04-2021: Phage Retention Nomenclature Rating for Small- and Large-Virus Retentive Filters
ANSI/PDA Standard 001-2020: Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industries
PDA Survey: 2025 PUPSIT Benchmarking Survey NEW
PDA Survey: 2025 Transportation Validation Benchmarking Survey
PDA Survey: 2024 PDA Annex 1: One Year into Implementation Survey
PDA Survey: Implementation of the New EU GMP Annex 1 and Implementation of Barrier Systems Survey
PDA Survey: Availability of Single-Use-System Components and its Potential Impact on Product Supply Survey Results
PDA Research: 2023 PDA Visual Inspection Survey (single user digital version)
PDA Research: 2020 Particulate Matter in Flexible Containers Survey (single user digital version)
PDA Research: 2021 Post-Approval Change Issues and Impacts Survey (single user digital version)
PDA Research: 2019 PDA Traceability of Primary Packaging Survey (single user digital version)
PDA Research: 2019 Sterile Lyophilized Drug Product Loading Survey (single user digital version)
PDA Research: 2019 Technology Transfer Industry Survey (single user digital version)
PDA Research: 2017 PDA Glass Quality Survey (single user digital version)
PDA Research: 2017 PDA PUPSIT Survey (single user digital version)
PDA Research: 2017 PDA Aseptic Processing Survey (single user digital version)
PDA Survey: 2015 Aging Facilities (single user digital version)
PDA Survey: 2015 Particulate Matter in Difficult to Inspect Parenterals (single user digital version)
PDA Survey: 2015 Particulate Matter in Oral Dosage Forms (single user digital version)
PDA Survey: 2014 Visual Inspection (single user digital version)
PDA Survey: 2014 Quality Culture Metrics (single user digital version)
PDA Survey: 2014 PDA Process Validation Survey (single user digital version)
PDA Survey: 2013 PDA Objectionable Microorganisms for Nonsterile Pharmaceutical, Consumer Health, Medical Devices, Dietary Supplement and Cosmetic Products (single user digital version)
PDA Survey: Glass Quality: 2011 and 2012 Results and Comparison (single user digital version)
PDA Survey: Business Case for Pharmaceutical Quality (single user digital version)
Risk Mitigation of Tribromoanisole (TBA)/Trichloroanisole (TCA) Taints and Odors: A Pharmaceutical Industry Benchmarking Survey (single user digital version)
PDA Research: 2021 PDA Aseptic Processing Simulation Survey (Single user digital version)
Quality Culture Metrics Pilot Report (single user digital version)
Pharmaceutical Regulatory Inspections (3rd Edition) NEW
Environmental Monitoring Volume 9
Quality Risk Management: A Practical Guide
Global Sterile Manufacturing Regulatory Guidance Comparison & Assessment Tool Second Edition
GMP Validation: A Guide to International Regulatory Requirements
Industrial Pharmaceutical Microbiology Quality Control
Industrial Pharmaceutical Microbiology Standards & Controls 6th Edition
Conducting Compliant Investigations
Quality by Design - An Indispensable Approach to Accelerate Biopharmaceutical Product Development (single user digital version)
Cleanroom Contamination Prevention & Control: A Practical Guide to the Science (single user digital version)
Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers, Volume 2: Digital Data, Insights, Metrics and Analytics (single user digital version)
Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers, Volume 1: Digital Technologies for Automation and Process Improvement (single user digital version)
Water Activity Applications in the Pharmaceutical Industry (single user digital version)
Root Cause Investigations for CAPA: Clear and Simple (single user digital version)
Software as a Service (SaaS): Risk-Based Validation with Time-Saving Templates (single user digital version)
FDA Warning Letters: Analysis and Guidance (single user digital version)
FDA Warning Letters: Analysis and Guidance (Hardcover)
Fungi: A Handbook for Life Science Manufacturers and Researchers (single user digital version)
Risk-Based Software Validation (Single user digital version)
Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 2 (single user digital version)
Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1 (Hardcover)
Biotechnology: From Idea to Market (single user digital version)
Biotechnology: From Idea to Market (Hardcover)
Audit and Control for Healthcare Manufacturers: A Systems-Based Approach (single user digital version)
PDA Technical Series: Endotoxin Analysis and Risk Management
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume 2 (single user digital version)
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume 1 (single user digital version)
PDA Technical Series: Pharmaceutical Glass
Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial Production (single user digital version)
Contamination Prevention for Nonsterile Pharmaceutical Manufacturing
Microbiological Culture Media: A Complete Guide for Pharmaceutical and Healthcare Manufacturers (single user digital version)
Torbeck`s Statistical Cookbook for Scientists and Engineers (single user digital version)
Environmental Monitoring: A Comprehensive Handbook, Volume 8 (single user digital version)
Aseptic and Sterile Processing: Control, Compliance and Future Trends (single user digital version)
Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 3 (single user digital version)
Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 2 (single user digital version)
Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 1 (single user digital version)
Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 4 (single user digital version)
Effective Implementation of Audit Programs (single user digital version)
Method Development and Validation for the Pharmaceutical Microbiologist (single user digital version)
Pharmaceutical Quality Control Microbiology: A Guidebook to the Basics (single user digital version)
Essential Microbiology for QP Candidates (single user digital version)
Biological Indicators for Sterilization Processes (single user digital version)
Recent Warning Letters Review for Preparation of a Non-Sterile Processing Inspection, Volume 2 (single user digital version)
Lifecycle Risk Management for Healthcare Products: From Research Through Disposal (single user digital version)
Recent Warning Letters Review for Preparation of an Aseptic Processing Inspection, Volume 1 (single user digital version)
Risk Assessment and Management for Healthcare Manufacturing: Practical Tips and Case Studies (single user digital version)
Contamination Control in Healthcare Product Manufacturing, Volume 4 (single user digital version)
Pharmaceutical Legislation of the European Union, Japan and the United States of America - An Overview, Updated and Expanded Second Edition
Assuring Data Integrity for Life Sciences (single user digital version)
Visual Inspection and Particulate Control (single user digital version)
Why Life Science Manufacturers Do What They Do in Development, Formulation, Production and Quality: A History (single user digital version)
Lessons of Failure: When Things Go Wrong In Pharmaceutical Manufacturing (single user digital version)
Trend and Out-of-Trend Analysis for Pharmaceutical Quality and Manufacturing Using Minitab (single user digital version)
Environmental Monitoring: A Comprehensive Handbook, Volumes 4, 5, 6 and 7
Environmental Monitoring: A Comprehensive Handbook, Volume 1, 2 and 3 (single user digital version)
Environmental Monitoring: A Comprehensive Handbook, Volume 4 (single user digital version)
Environmental Monitoring: A Comprehensive Handbook, Volume 5 (single user digital version)
Environmental Monitoring: A Comprehensive Handbook, Volume 6 (single user digital version)
Environmental Monitoring: A Comprehensive Handbook, Volume 7 (single user digital version)
Microbial Risk and Investigations (single user digital version)
Computerized Systems in the Modern Laboratory: A Practical Guide (single user digital version)
Encyclopedia of Rapid Microbiol Methods, Volume 4
Encyclopedia of Rapid Microbiological Methods, Volumes 1, 2 and 3 (single user digital version)
Cleaning and Cleaning Validation, Volumes 1 and 2 (single user digital version)
Rapid Sterility Testing (single user digital version)
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volumes 1 and 2 (single user digital version)
Practical Aseptic Processing Fill and Finish, Volumes 1 and 2 (single user digital version)
Thermal Validation in Moist Heat Sterilization (single user digital version)
Validating Enterprise Systems: A Practical Guide (single user digital version)
Laboratory Design: Establishing the Facility and Management Structure (single user digital version)
Validation by Design: The Statistical Handbook for Pharmaceutical Process Validation (single user digital version)
Biofilm Control in Drug Manufacturing (single user digital version)
Sterility Testing of Pharmaceutical Products (single user digital version)
Risk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple (single user digital version)
The Bacterial Endotoxins Test: A Practical Guide (single user digital version)
Quality By Design: Putting Theory Into Practice (single user digital version)
Pharmaceutical Outsourcing: Quality Management and Project Delivery (single user digital version)
Technology and Knowledge Transfer: Keys to Successful Implementation and Management (single user digital version)
Cleanroom Microbiology (single user digital version)
Square Root of (N) Sampling Plans: Procedures and Tables for Inspection of Quality Attributes (single user digital version)
Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volumes 1, 2 & 3 (single user digital version)
Cold Chain Chronicles: A practitioners outside-the-box perspectives on the importance of temperature-sensitive drug stewardship (single user digital version)
Environmental Monitoring: A Comprehensive Handbook, Volume 3 (single user digital version)
Environmental Monitoring: A Comprehensive Handbook, Volume 2 (single user digital version)
Environmental Monitoring: A Comprehensive Handbook, Volume 1 (single user digital version)
Contamination Control in Healthcare Product Manufacturing, Volumes 1, 2 & 3 (single user digital version)
Contamination Control in Healthcare Product Manufacturing, Volume 2 (single user digital version)
Contamination Control in Healthcare Product Manufacturing, Volume 3 (single user digital version)
Risk-Based Compliance Handbook (single user digital version)
Systems Based Inspection for Pharmaceutical Manufacturers (single user digital version)
Validation of Analytical Methods for Biopharmaceuticals: A Guide to Risk-Based Validation and Implementation Strategies (single user digital version)
Microbial Identification: The Keys to a Successful Program (single user digital version)
Contamination Control in Healthcare Product Manufacturing, Volume 1 (single user digital version)
Combination Products: Implementation of cGMP Requirements
Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 3 (Hardcover)
Ethylene Oxide Sterilization Validation and Routine Operations Handbook (single user digital version)
Microbial Risk Assessment in Pharmaceutical Clean Rooms (single user digital version)
Microbiological Monitoring of Pharmaceutical Process Water (single user digital version)
Environmental Monitoring: A Comprehensive Handbook, Volume 4 (Hardcover)

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