Good Drug Regulatory Practices: A Regulatory Affairs Quality Manual / Edition 1

by Helene I. Dumitriu

Overview

Good Drug Regulatory Practices offers a series of policies and procedures to assure quality and timely regulatory submissions to national regulatory agencies. This book begins with introductory chapters describing the need for policy documentation, and the philosophy underlying the policies, and presents policies and standards that can be used as presented or adapted to individual situations in your company.

Product Details

ISBN-13:	9780367448080
Publisher:	CRC Press
Publication date:	12/02/2019
Pages:	440
Product dimensions:	7.00(w) x 10.00(h) x (d)

Table of Contents

Part I: The Regulatory Affairs Quality System 1. Historical Overview 2. Good Regulatory Practice: The Application of Quality Management to Regulatory Affairs 3. Check Your Quality System Part II: The Regulatory Affairs Quality Manual 4. The Quality Manual Explained 5. The Philosophy behind the Policies 6. Policies 7. Standards