Analytical Methods, Specifications and Control Strategies for a GxP Environment (Chromatographic Science Series)

By Terrence P. Tougas, Dennis O'Connor, Cornelia Field

This book provides information about the analytical methods and strategies for quality control of clinical supplies and commercial products in the pharmaceutical industry. It describes the analytical methods used, presents an overview of validation and method transfer, and discusses the strategy for establishment of specifications. The text addresses the types of studies needed to support development and details a phased approach to development. It also explains how the development cycle relates to analytical development guidance on designing a control strategy and to quality by design. The authors conclude with commentary on the current regulatory environment.

• Format: Hardcover
• Language: English
• ISBN: 1439879664
• ISBN13: 9781439879665
• Release Date: December 2023
• Publisher: CRC Press
• Length: 360 Pages