Good Drug Regulatory Practices

Helene I. Dumitriu

Detalles del libro
Editorial: CRC Press
ISBN: 1-57491-051-5
ISBN-13: 9781574910513
Materia: Libros de Farmacologia
Good Drug Regulatory Practices offers a complete plan for meeting the essential quality, quality control, and quality assurance necessary to achieve the objectives of their operation. By assessing global product development in the EU, Japan, and the US, Dr. Dumitriu presents the foundation of quality management, and discusses the evolution of regulatory bodies in the pharmaceutical industry, including regulatory agencies, associations, and the development of GMP, GCP, and GLP. He goes on to describe the application of quality management to Good Practice, and provides an extremely thoughtful Quality Systems Questionnaire, with answers, to help readers assess their current situations.