Good Drug Regulatory Practices
A Regulatory Affairs Quality Manual
Seiten
1997
Crc Press Inc (Verlag)
978-1-57491-051-3 (ISBN)
Crc Press Inc (Verlag)
978-1-57491-051-3 (ISBN)
This book attempts to be the first systematic treatment on what should now be named Good Drug Regulatory Practice (GDRP). It covers regulatory affairs regarding global product development for the European Union, Japan, and the United States.
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.
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.
Dumitriu, Helene I.
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
Erscheint lt. Verlag | 30.9.1997 |
---|---|
Verlagsort | Bosa Roca |
Sprache | englisch |
Maße | 178 x 254 mm |
Gewicht | 970 g |
Themenwelt | Sachbuch/Ratgeber ► Gesundheit / Leben / Psychologie |
ISBN-10 | 1-57491-051-5 / 1574910515 |
ISBN-13 | 978-1-57491-051-3 / 9781574910513 |
Zustand | Neuware |
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