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This American National Standard (ANS) evaluates various guidance documents, models, and tools to measure and provide a better understanding of quality culture for the pharmaceutical/medical device industry. The standard identifies 5 key focus topics with attributes, characteristics, and measurements …

This standard provides a lifecycle approach using a holistic evaluation of contamination control systems designed to minimize and/or prevent contamination during aseptic processing and ultimately ensure the safety of the products when delivered to the patient. The standard is also applicable to aseptic …

Technical Report No. 41 (Revised): Virus Retentive Filtration, provides a summary of best practices for utilization of virus filtration in process development and manufacturing. The document explains what virus filters are and where they can be used in current and emerging bioprocesses. Recommendations …

This technical report presents a holistic approach for performing a microbiological investigation. It provides a framework to assist with focusing on the investigational areas that may contain or contribute to the root cause of data deviations, such as sampling, test methodology, and suitability of the …

This technical report is a consensus-based resource surrounding the challenges encountered in using complex package systems and introduces important elements to consider in decision-making. It also offers an examination of the technologies available for package integrity testing not yet established by …

Visual inspection of filled injectable products is an important part of the control strategy of the manufacturing process. It offers a means to improve quality by removing noncompliant units and provides information to drive continuous process improvement. This technical report addresses test and inspection …

In this book you will find many different approaches to conducting compliant investigations, where compliant is defined as meeting the requirements of the applicable regulatory documents. The information it provides on conducting investigations that will be acceptable to regulatory investigators will …

This chapter is taken from the book Fungi: A Handbook for Life Science Manufacturers and Researchers, edited by Jeanne Moldenhauer.There is a major gap in understanding fungi in general and mold specifically in the pharmaceutical industry. Most mycologists are in academia and fungi are not taught in …

This timely and informative text discusses aspects of contamination control in cleanrooms seldom described in detail in the literature. The increasing number of warning letters, product recalls and 483 observations related to both particulate and microbial contamination indicates that contamination control …

This first-of-two volume release from prolific author Tim Sandle fills an important void by taking an in-depth look at the way digital technologies are impacting the pharmaceutical and healthcare landscape both now and into the future. He explores how companies have been embracing digital technologies …

This first-of-two volume release from prolific author Tim Sandle fills an important void by taking an in-depth look at the way digital technologies are impacting the pharmaceutical and healthcare landscape both now and into the future. He explores how companies have been embracing digital technologies …

This Points to Consider document was developed as part of the PDA/BioPhorum Sterilizing Filtration Quality Risk Management Consortium. It provides the reader with points to consider on how to best implement and execute a pre-use/post-sterilization integrity test (PUPSIT) of the final sterilizing grade …

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 requirements, roles …

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 …

Are you prepared for recalls relating to pharmaceutical and healthcare medications and medical devices? This book contains details about recalls from start to finish, including advice on how to handle a recall and, more importantly, how they can be avoided. Read about regulatory perspectives, trends …

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 …

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 …

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 …