Publications
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PDA Technical Report No. 79 (TR 79) Particulate Matter Control in Difficult to Inspect Parenterals (single user digital version)
PDA Technical Report No. 79, Particulate Matter Control in Difficult to Inspect Parenterals describes best practices for difficult to inspect (DIP) product lifecycle management, destructive testing, and trending to supplement portions of the guidance given in USP General Chapter <1790>: Visible Particulates in Injection. This Technical Report is intended to provide logical pathways to DIP product inspection and testing to support continual process improvement in the industry. -
PDA Technical Series: Pharmaceutical Glass (single user digital version)
The PDA Technical Series: Pharmaceutical Glass is a collection of articles previously published in the PDA Journal of Pharmaceutical Science and Technology. This book organizes 19 articles on glass published between 2007 and 2017 into four categories: Overview, Material Composition, Delamination, and Quality Methods. -
Risk Management Library Volume 7, Risk Problem Solvers: Inadequate Facilities, Procedures and Process Control (single user digital version)
This Volume describes 24 problems and offers solutions regarding everything from bioburden contamination in a contained water system to filter integrity, customer complaints, process control failures, and many more real-world problems that were solved with adequate investigations.
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Risk Management Library Volume 6, Risk Problem Solvers: Lack of Process Understanding (single user digital version)
This Volume discusses diagnosis and corrective actions to common problems, such as incorrect batch records, contaminated product complaints, contamination, environmental monitoring, and many other subjects.
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Risk Management Library Volume 5, Risk Problem Solvers: Failure to Follow Established Procedures (single user digital version)
Sometimes even well-designed systems are thwarted by human behavior causing a series of blunders that common sense says could not have happened. In this Volume, you’ll find ten examples and solutions to problems arising from failure to follow established procedures.
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Risk Management Library Volume 4: Practical Approaches to Risk Assessment and Management Problem Solving: Tips and Case Studies (single user digital version)
Receive expert guidance on major topics, such as regulatory perspectives on risk and five insightful case studies to help develop the best approaches to problem solving based upon the "what if" and "five whys" method.
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Risk Management Library Volume 3: Practical Approaches to Risk Assessment and Management (single user digital version)
In this Volume, well-respected global experts give an overview of the risk management process and the tools required, including risk-related documents and records and techniques for auditing a risk management program.
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Risk Management Library Volume 2: Practical Approaches to Risk-Based Compliance (single user digital version)
This Volume offers guidance in implementing process analytical technology (PAT), discusses the challenges and pitfalls of applying a science and risk-based approach in research and manufacturing, and presents documented evidence for risk-based compliance.
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Risk Management Library Volume 1: Lifecycle Risk Management (single user digital version)
Written by experienced authors, this Volume offers insight into the risk management processes, management considerations, and strategies in product development, implementation of risk management for non-product software, and the future of risk management
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Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial Production (single user digital version)
This book provides succinct and practical guidance on how to develop a biological drug product and, at the same time, stay within the regulatory expectations at each phase of the development process! -
PDA Research: 2017 PDA PUPSIT Survey (single user digital version)
In March of 2017, PDA conducted a benchmarking survey to better understand the current situation regarding sterile filtration and the implementation of Pre-Use Post Sterilization Integrity Test, or PUPSIT, among large pharmaceutical companies. -
Contamination Prevention for Nonsterile Pharmaceutical Manufacturing (single user digital version)
The handbook on Contamination Prevention for Nonsterile Pharmaceutical Manufacturing offers guide-lines for best practices to be deployed within a manufacturing facility. It explains where the most common microbiological risks to nonsterile manufacturing reside and how to prevent contamination in the key areas. -
PDA Technical Report No. 78 (TR 78) Particulate Matter in Oral Dosage Forms (single user digital version)
PDA Technical Report No. 78, Particulate Matter in Oral Dosage Forms documents the current practices used by manufacturers of drug products, active pharmaceutical ingredients, excipients, and packaging/primary containers to control, inspect, sample, and test intrinsic and extrinsic particulate matter in oral dosage forms. The scope of this Technical Report includes current practices of monitoring for particulates, as well as recent quality, clinical relevance, and regulatory experience in oral dosage forms. -
PDA Research: 2017 PDA Aseptic Processing Survey (single user digital version)
The 2017 PDA Aseptic Processing Survey explores aseptic processing practices for global secondary manufacturing (finished product filling/packaging), while taking into consideration the changes and needs of the modern, global, sterile, healthcare product manufacturing industry. -
Microbiological Culture Media: A Complete Guide for Pharmaceutical and Healthcare Manufacturers (single user digital version)
This unique text looks at how media is used in the modern pharmaceutical microbiology setting, while taking innovative new media "recipes" into account. It is dedicated to the use of culture media in the pharmaceutical microbiology setting. In 23 chapters, the book recaps the past, signals the future, and helps interpret the present. -
Quality Culture Metrics Pilot Report (single user digital version)
This report is only available to individuals who participated in the PDA Quality Culture Pilot.
For more information on PDA Quality Culture Transformation Resources, please contact Stephanie Ko (ko@pda.org)
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Torbeck`s Statistical Cookbook for Scientists and Engineers (single user digital version)
In the Statistical Cookbook for Scientists and Engineers, you will find tried and true, practical statistical “recipes” that provide a book of specific and unique statistical modules useful for evaluation of industrial studies. These modules are designed for the busy industrial worker, who needs to apply statistical techniques with the assurance they are using the technique correctly. -
Torbeck`s Statistical Cookbook for Scientists and Engineers (Hardcover)
In the Statistical Cookbook for Scientists and Engineers, you will find tried and true, practical statistical “recipes” that provide a book of specific and unique statistical modules useful for evaluation of industrial studies. These modules are designed for the busy industrial worker, who needs to apply statistical techniques with the assurance they are using the technique correctly. -
Environmental Monitoring: A Comprehensive Handbook, Volume 8 (single user digital version)
Volume 8 of the Environmental Monitoring Handbook series is a mixture of new topics and new takes on previously discussed topics. In this volume, you will find information about regulatory/compendial updates, testing methods, risk methods and tools, and routine (and non-routine) monitoring.
This volume is a must have for anyone involved with environmental monitoring! -
Environmental Monitoring: A Comprehensive Handbook, Volume 8 (Hardcover)
Volume 8 of the Environmental Monitoring Handbook series is a mixture of new topics and new takes on previously discussed topics. In this volume, you will find information about regulatory/compendial updates, testing methods, risk methods and tools, and routine (and non-routine) monitoring.
This volume is a must have for anyone involved with environmental monitoring!
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