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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 …

PDA Technical Report No. 46 (Revised 2024): Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to End Users complements the information provided in Technical Report No. 39 (Revised 2021): Guidance for Temperature-Controlled Medicinal Products — Maintaining the Quality …

This document provides points to consider on topics related to the physical environment in which aseptic processing is conducted, monitoring of that environment, cleanroom personnel, material transfer, aseptic process simulation and validation, modern blow-fill-seal technology, cleaning, disinfection …

Drug manufacturers have employed contamination control measures for decades as a core element of good manufacturing practices. Commonly, these are a collection of generic practices that were developed separately and applied without clear consideration for their interdependence. The ongoing evolution …

This report describes different strategies that can be applied to manage the development and lifecycle of vaccine products. The concepts covered are intended to apply to different types of vaccines, for which "real world" examples are provided. In some cases, the strategy may involve extensive retrospective …

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 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 …

PDA's Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration summarizes the processes and outcomes of the risk Assessment and control mapping exercises performed as part of the PDA/BioPhorum Sterilizing Filtration Quality Risk Management Consortium. It describes …

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 …

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 …

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 …

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 …