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This book has been prepared to address the requirements which are stated in the Guide to the Knowledge and Practical Experience Required by Qualified Persons in the Pharmaceutical Industry (the "Study Guide") in relation to pharmaceutical microbiology.This reference guide will help QP candidates …

This book discusses the basic concepts necessary to the understanding of Biological Indicators and includes the history of biological validation and general principles, the kinetics of microbial inactivation and factors affecting resistance as well as guidance in understanding bacterial endospores …

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 …

The focus of this book is to provide a way to prepare for an FDA inspection of a non-sterile facility by reviewing relevant Warning Letters recently issued. The number of Warning Letters issued by FDA has been rising in recent years. The FDA publishes Warning Letters in its Electronic Reading Room available …

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 …

The focus of this book is to provide a way to prepare for a FDA inspection of an aseptic facility by reviewing Warning Letters recently issued to pharmaceutical companies. The number of Warning Letters issued by FDA has been rising in recent years. The FDA publishes Warning Letters in its Electronic …

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 …

Aging facilities contribute to a variety of challenges in pharmaceutical manufacturing, including drug shortages and product recalls. In response to calls for support in this area from industry and regulators, PDA established an Aging Facility Task Force to focus on the identification and modernization …

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 …

Edited by experts and written by global subject matter professionals, this vital addition to the Contamination Control series offers new chapters covering current, relevant information including:Regulatory changes relative to ISO 14644, Parts 1 and 2 Updates to ISO 11737-1 Risks of spores including preventive …

Edited by experts and written by global subject matter professionals, this vital addition to the Contamination Control series offers new chapters covering current, relevant information including:Regulatory changes relative to ISO 14644, Parts 1 and 2 Updates to ISO 11737-1 Risks of spores including preventive …

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 …

Due to the lack of detailed guidance and best practices for inspection and particle control in difficult to inspect parenteral (DIP) products, PDA has established a technical report team to address particulate matter in difficult to inspect parenterals. As a first step in developing a better understanding …

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 …

Particulate matter in oral dosage forms has been the subject of customer complaints, recalls and regulatory actions. However, there is currently no clear industry standard or guidance on mitigation, acceptance criteria, clinical relevance, inspection, sampling, testing or acceptable complaint levels …

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 …