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Technical Report No. 80: Data Integrity Management System for Pharmaceutical Laboratories
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This Technical Report, developed by subject matter experts from the global pharmaceutical industry and regulatory agencies, provides the framework and tools necessary to establish a robust data integrity management system to ensure data integrity for paper, hybrid, and computerized systems within the … -
GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, Fifth Edition, Revised & Expanded (single user digital version)
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The Long-Awaited Revision and Update of GMP in Practice is Here! Have you ever asked yourself, "Where in the Good Manufacturing Practices (GMPs) does it say I have to do _______?" If so, look no further than PDA's GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, fifth … -
Microbial Control and Identification: Strategies Methods Applications (single user digital version)
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In PDA's latest release, expert microbiologists and biopharmaceutical industry leaders explore the role of microbial identification knowledge as a cornerstone in the concept of microbial and contamination control programs. This book is an excellent reference for new microbiologists and seasoned professionals … -
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume 2 (single user digital version)
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Clearance Sale - 20% off! Original Price US$235 PDA Member, US$289 Nonmember, US$155 Government Sale prices are already displayed and will be reflected during checkoutThe first edition of Microbiology in Pharmaceutical Manufacturing, published in 2001, is THE best selling PDA/DHI book of all time. … -
PDA Research: 2017 PDA Glass Quality Survey (single user digital version)
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The 2017 PDA Glass Quality Survey is designed to assist in the identification of glass container quality concerns and development of solutions to overcoming them. Survey topics include glass sampling and inspection practices, product complaints and recalls due to glass defects, and quality … -
Technical Report No. 79: Particulate Matter Control in Difficult to Inspect Parenterals
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PDA Technical Report No. 79, Particulate Matter Control in Difficult to Inspect Parenterals describes best practices for difficult to inspect parenteral (DIP) product lifecycle management, destructive testing, and trending to supplement portions of the guidance given in USP General … -
Risk Management Library Volume 7, Risk Problem Solvers: Inadequate Facilities, Procedures and Process Control (single user digital version)
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Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Risk Management Library Volume 6, Risk Problem Solvers: Lack of Process Understanding (single user digital version)
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Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Risk Management Library Volume 5, Risk Problem Solvers: Failure to Follow Established Procedures (single user digital version)
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Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Risk Management Library Volume 4: Practical Approaches to Risk Assessment and Management Problem Solving: Tips and Case Studies (single user digital version)
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Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Risk Management Library Volume 3: Practical Approaches to Risk Assessment and Management (single user digital version)
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Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Risk Management Library Volume 2: Practical Approaches to Risk-Based Compliance (single user digital version)
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Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Risk Management Library Volume 1: Lifecycle Risk Management (single user digital version)
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Pharmaceutical and Biopharmaceutical Manufacturing: Understanding Your Process Series The U.S. FDA plans to take a risk-based approach to biomanufacturing inspection and changes are expected very soon. With regulatory expectations and the impending changes anticipated in 21CFR 600 in June 2018, now is … -
Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial Production (single user digital version)
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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!Within this book, you can find chapters on:Current manufacturing and process development of Regenerative … -
PDA Research: 2017 PDA PUPSIT Survey (single user digital version)
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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. Due to increased enforcement of section 113 of Annex 1 by … -
Contamination Prevention for Nonsterile Pharmaceutical Manufacturing
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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 … -
Technical Report No. 78: Particulate Matter in Oral Dosage Forms
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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 … -
PDA Research: 2017 PDA Aseptic Processing Survey (single user digital version)
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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. Results are based on 304 … -
Torbeck`s Statistical Cookbook for Scientists and Engineers (single user digital version)
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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 … -
Environmental Monitoring: A Comprehensive Handbook, Volume 8 (single user digital version)
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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 …
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