Principles of Parenteral Solution Validation: A Comprehensive Guide

Authored by Igor Gorsky, Principles of Parenteral Solution Validation: A Practical Lifecycle Approach is an exhaustive resource that delves into the intricacies of developing and validating parenteral products. This book employs a lifecycle approach, encompassing the latest technological advancements, compliance developments, and regulatory considerations and trends that affect the pharmaceutical industry.

A Holistic Understanding of Parenteral Solution Validation

This book provides in-depth coverage of every aspect involved in the development and process validation of parenteral products, from process design to divestment. The author’s expertise shines through in the discussion of risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more.

Regulatory Considerations and Timely Solutions

What sets this book apart is its focus on both international and domestic regulatory considerations, which are addressed in every section. The inclusion of callout boxes containing points-of-interest for each segment of the audience allows readers to quickly find the information that is most relevant to their needs and interests.

Real-World Examples and Case Studies

The book incorporates numerous case studies and real-world examples that address the daily challenges faced by practitioners in the pharmaceutical industry. These examples provide timely solutions to pressing problems, making this book an indispensable resource for professionals in this field.

Product Details
Publisher: Elsevier Science
Publication Date: November 27, 2019
Language: English
ISBN: 9780128094129, 9780128094464