Risk management in pharmaceutical production

This book provides a step-by-step guide to understanding the concept of risk management for the quality of medicinal products, based on common sense, a systemic approach, and regulatory expectations. The value of the book lies in its simplicity. There are no complex formulas, models, or sad theories. It is a well-written and structured source of essential knowledge. The book helps to grasp the essence of risk management methodology by providing practical examples. 
 
Each chapter is written by a separate author who used examples from the practice of real, well-known pharmaceutical companies. This helps the reader to gain a more diverse perspective on risk assessment during drug development, development of samples for official studies, manufacturing under different conditions, qualification and validation, as well as change control.