Good Research Practices: A Practical Guide to the Implementation of the GXPs

by Nigel Dent

This book has been designed as a practical guide to implementing good research and quality practices.The need for audits and quality assurance is increasing as industry is having to validate its results to an even greater extent. The term GxP has now been coined for many of these good practices. In addition to the main ones mentioned, GMP, GLP and GCP, we are seeing an evolution of similar guidelines throughout the industry.* covers practical problems of auditing multinational studies* good introduction to the regulatory agencies and review of the World Health Organisation* overall review of computers and the validation of the computer database to comply with GLP and GCP specifically* the expert authors have been chosen for their specific in-dept knowledge of the subject about which they have written.This practical guide will prove invaluable for scientists, regulators and research workers in quality management and quality assurance.

Hardcover

First published December 25, 1996