Preparing for FDA Pre-Approval Inspections is designed to help those involved in product development understand the FDA requirements for the manufacture of clinical trial material and product development activities. The goal is speeding up the pre-approval process. Chapter one defines and provides an overview of the pre-NDA approval inspection. In chapter two, a strategic approach to preparing for an inspection is covered. Subsequently, the book discusses key inspection areas, how best to manage the inspection process, consequences of failing the pre-approval inspection, and more.
Different contributors author the chapters but all follow a similar clear format.
Tables and drawings are sprinkled liberally throughout the book, and bibliographic references and an index are included. Recommended for pharmaceutical libraries, scientists working in pharmaceutical manufacturing, regulatory personnel and others concerned with drug quality assurance. Inc. All rights reserved.