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PDA's Points to Consider for Sensitivity to Oxidation by Peroxide addresses aspects to consider in the design, development, processing, instrumentation, materials, and equipment specific to issues with products sensitive to oxidation when exposed to H2O2. This document primarily applies to isolator …

This text, based on workshops led by instructor and author James Vesper, provides practical tools for both a thorough understanding of risk-based CAPA investigations and regulatory acceptable applications.Beginning with topics such as why and how much investigations matter, regulatory …

Focusing on important regulatory and technical updates surrounding isolator design, validation, and operations for aseptic processing, this Points to Consider addresses two primary types of isolators - open and closed - and is intended to support identification and use of modern technology. It does not …

This publication provides a summary and analysis of publicly available yearly observation data for drug product manufacturers from the U.S. FDA and presents it in a more useful, digestible format. It includes an analysis of trends in observations and a breakdown of the most common observations from …

The best way to handle Warning Letters issued by the U.S. FDA is to prevent them. This text identifies and discusses those Letters recently issued, offers analysis, and provides guidance to help readers avoid receiving such a letter.In addition to the Warning Letter summaries there is discussion of …

This text can help identify and ameliorate fungal and mold problems and contains a wealth of information as a guide and reference. Many topics are discussed relevant to the food and agriculture industries, including the biology of fungi, outbreaks associated with pharmaceutical drug products and medical …

This survey is designed to align and expand PDA's insight on current practices for companies that manufacture sterile lyophilized drug products and conduct lyophilizer loading. It also provides insight into how today's lyophilizer loading area operations can be improved to reduce contamination from …

The fifth volume to PDA's popular series, Contamination Control in Healthcare Product Manufacturing, explores practical approaches to leverage environmental monitoring data to improve performance, how to design a risk-based environmental monitoring program for non-sterile manufacturing, the clinical …

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 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 …

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 …

In Destin LeBlanc's Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Vol. 3 pharmaceutical manufacturers and upper management are encouraged to meet the challenges of the science-based and risk-based approaches to cleaning validation.Volume 3, a complement to …

This book complements Cleaning Validation: Practical Solutions for Pharmaceutical Manufacturing, Volume 1. It contains modifications and updates of the author`s monthly Cleaning Memos originally published from January 2005 through December 2008. In both volumes, each Cleaning Memo is presented as …

Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing by Destin LeBlanc contains a complete, modified and updated collection of his Cleaning Memos from 2000 through 2004, all organized by topic rather than chronologically. The only memo not included dealt with cleaning …

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 …