Good Drug Regulatory Practices : A Regulatory Affairs Quality Manual

ISBN-13: 9781574910513 / Angielski / Twarda / 1997 / 440 str.

Helene Dumitriu; Dumitriu I. Dumitriu

Opis

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.

Spis treści

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

O autorze

Dumitriu, Helene I.