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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 …

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 …

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 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 …

Volume 4 complements Destin LeBlanc's earlier three books on the same subject. This book modifies and updates LeBlanc's monthly Cleaning Memos originally published from January 2013 through December 2016. More than half of the chapters in the book are on setting limits in one way or another, so the use …

The book primarily focuses on parenteral products and the excipients, but the methodology can transfer to other areas of microbiology as well. The book also provides advice on programs and special studies that might be performed in the pharmaceutical microbiology laboratory. The purpose of this book …

This book is intended to provide a background to the quality control (QC) microbiology function from the perspective of the laboratory, and particularly from that of the laboratory manager. Sutton focuses on the role of the QC microbiology laboratory in the pharmaceutical manufacturing …

PDA’s newly revised PDA Technical Report No. 56, Revised 2016 Application of Phase-Appropriate Quality System and cGMP to the Development of Therapeutic Protein Drug Substance provides an overview of the ideal state for broad good manufacturing practices (GMPs) throughout the product lifecycle and as …

This book provides current information on the risk management process as it applies to health and safety of health products, drugs and biologics, medical devices and products that are a combination of two or more of these. The application of the processes will help manufacturers of these products to …

PDA's newly released Technical Report No. 76 (TR 76) Identification and Classification of Nonconformities in Elastomeric Closures and Aluminum Seals for Parenteral Packaging provides a building block for developing a comprehensive specification for elastomeric components and aluminum seals. It offers …

Avoidance of hazards and assessment of risk have long been part of the manufacture of pharmaceuticals and healthcare products. A high quality drug product must be free from contamination and reliably deliver the intended therapeutic dose as stated on the label and to achieve this manufactures must always …

PDA's newly released Technical Report No. 75 (TR 75) Consensus Method for Rating 0.1µm Mycoplasma Reduction Filters describes a consensus filter challenge test for standardizing test parameters across laboratories. This report educates users and filter manufacturers about best practices for mycoplasma …

This technical report provides guidance in the design, development, controls, procedures, validation, regulatory submission and implementation of reprocessing procedures for biopharmaceutical manufacturing. It focuses on recombinant biopharmaceutical products, including proteins and polypeptides produced …

Whether you are a student, a newcomer to the pharmaceutical industry or a seasoned professional, the second edition of this book has something for everyone. The book presents a condensed overview of the regulatory systems and processes for marketing a drug product in the three major global regions: …

This new book provides a truly global perspective on data integrity and the solutions available to address this serious issue. It includes two main sections: the regulatory and historic background of data integrity, and practical advice on how to prevent or rectify data integrity breaches.Each chapter …

This book is a practical guide for the control of visible defects and contamination in pharmaceutical products. It is intended for the product inspectors and lab support personnel, as well as those who use inspection results or are responsible for inspection operations. Meant to familiarize and educate …

Sale - 20% off!Original Price US$210 PDA Member, US$259 Nonmember, US$190 Government Sale prices are already displayed and will be reflected during checkoutIn a passionate retrospective of a successful career built on thinking statistically and applying that approach to quality in pharmaceutical …

Russ Madsen and Maik Jornitz have assembled fascinating stories from renowned industry practitioners who share their global work experiences to highlight root cause analysis and problem solving. Each story is written as a brief lesson that begins with a statement of the problem, the steps taken to analyze …