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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 …

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 …

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 …

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 …

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 …

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 …

Taking into account that 90 percent of quality control microbiology remains reliant upon culture based methods, this unique text focuses on microbiological culture media as applied to pharmaceutical microbiology. This book takes into consideration that innovations continue to arise with new media recipes …

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 …

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 …

PDA's Points to Consider for Aging Facilities takes into account the industry's general thoughts and suggestions of the pharmaceutical manufacturing industry on how to identify and modernize aging facilities. This document reviews:How to recognize that a facility is aging Impediments to modernization …

Here is the most important text discussing aseptic and sterile manufacturing to be published in the last decade that looks at both today and tomorrow in regard to these two vital processing procedures.The Editors realized that there was an urgent imperative for the relevant subjects to be reassessed …

PDA's Technical Report No. 54-5, Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems provides practical guidance on how to manage quality risks throughout the manufacturing system lifecycle and illustrates concepts through two case studies. The information …

Sale - 20% off! Original Price US$265 PDA Member, US$329 Nonmember, US$180 Government Sale prices are already displayed and will be reflected during checkoutIn Destin LeBlanc's Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Vol. 3 pharmaceutical manufacturers and …

Sale - 20% off! Original Price US$265 PDA Member, US$329 Nonmember, US$180 Government Sale prices are already displayed and will be reflected during checkoutThis book complements Cleaning Validation: Practical Solutions for Pharmaceutical Manufacturing, Volume 1. It contains modifications and updates …

Sale - 20% off! Original Price US$265 PDA Member, US$329 Nonmember, US$180 Government Sale prices are already displayed and will be reflected during checkoutCleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing by Destin LeBlanc contains a complete, modified and updated …

Pharmaceutical Manufacturing: Understanding Your Process Series Environmental Monitoring, Volume 2: Practical ApproachesIn the past 15 years, PDA/DHI has published more than 1,000 practical scientific and regulatory chapters, written by global subject matter experts, which have been designed to help …

Pharmaceutical Manufacturing: Understanding Your Process Series Environmental Monitoring, Volume 1: Establishing the ProcessIn the past 15 years, PDA/DHI has published more than 1,000 practical scientific and regulatory chapters, written by global subject matter experts, which have been designed to …

Pharmaceutical Manufacturing: Understanding Your Process Series Sterilization: Practical ApproachesIn the past 15 years, PDA/DHI has published more than 1,000 practical scientific and regulatory chapters, written by global subject matter experts, which have been designed to help pharmaceutical and …

Pharmaceutical Manufacturing: Understanding Your Process Series Sterilization: Establishing the ProcessIn the past 15 years, PDA/DHI has published more than 1,000 practical scientific and regulatory chapters, written by global subject matter experts, which have been designed to help pharmaceutical …

Pharmaceutical Manufacturing: Understanding Your Process Series Cleaning and CleanroomsIn the past 15 years, PDA/DHI has published more than 1,000 practical scientific and regulatory chapters, written by global subject matter experts, which have been designed to help pharmaceutical and biotech manufacturers …