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This document provides key Points to Consider for navigating the complexities of raw materials in the manufacturing of advanced therapy medicinal products (ATMP), aiming to guide stakeholders in establishing robust strategies for raw material management, promoting best practices, and supporting the safe …

Hardcopies are available for purchase on the Euromed Communications website.This book contains practical advice and insight to help different types of pharmaceutical organisations prepare for GMP inspections, understand key regulatory issues and review inspectorate trends and findings. The book compares …

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 …

The Product Quality Research Institute (PQRI) Leachables and Extractables (L&E) Working Group provided recommendations to the US Food and Drug Administration in 2006 on safety thresholds and best demonstrated practices for orally inhaled and nasal drug products (OINDP). The published PQRI E&L …

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 …

The 2021 PDA Post-Approval Change Issues and Impacts Survey provides experts' views on the most significant post-approval change issues faced by manufacturers of drug products (DPs) and active pharmaceutical ingredients (APIs). By understanding the challenges that industry faces in making manufacturing …

The form FDA 483, "Inspectional Observations," is a form used by the FDA to document and communicate concerns discovered during the inspections of medical device manufacturing plants. This booklet takes the publicly available yearly inspection data from the U.S. FDA and presents it in a more …

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 form FDA 483, "Inspectional Observations," is a form used by the FDA to document and communicate concerns discovered during the inspections of biological manufacturing plants. This booklet takes the publicly available yearly inspection data from the U.S. FDA and presents it in a more useful, …

This chapter is reprinted and available individually from Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1 edited by Siegfried Schmitt, a text that collects in one place invaluable and comprehensive regulatory, manufacturing and distribution guidance and …

This chapter is reprinted and available individually from Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1 edited by Siegfried Schmitt, a text that collects in one place invaluable and comprehensive regulatory, manufacturing and distribution guidance and …

This chapter is reprinted and available individually from Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1 edited by Siegfried Schmitt, a text that collects in one place invaluable and comprehensive regulatory, manufacturing and distribution guidance and …

**Winter Booksale: 50% OFF! Limited Quantity Available!** 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 …

**Winter Booksale: 50% OFF! Limited Quantity Available!**PDA's latest professional resource, Biotechnology: From Idea to Market, is an invaluable guide and reference for anyone involved in the development of a product, from idea generation through commercialization. The goal of this book is to provide …