Publisher's Synopsis
This book has been written to meet the need for practical, authoritative and detailed advice for the quality assurance professional who is responsible for monitoring compliance with legal requirements and accepted standards, as embodied in the disciplines of good laboratory practice (GLP). GLP regulations concern the quality and integrity of safety data generated in industrial laboratories, in environmental studies and in the development of new chemical substances. They deal with such matters as: selection and training of staff; the handling of test materials; choice of test method; quality of measurements; maintenance and calibration of equipment; and sample and data curation.;Similar principles are adopted for assuring the quality of clinical research practice and of the manufacture of certain consumer products: GCRP applies mainly to the pharmaceuticals industry; GMP was introduced primarily to control the quality of drugs in manufacture. The same standards are being adopted in other personal product areas such as cosmetics, toiletries and dental products. These principles and requirements are increasingly applied also to work carried out in support of studies governed by "good practice" standards, such as characterization and chemical analysis.;This book should appeal to quality assurance auditors, QA personnel, study directors, facility managers, toxicologists, ecotoxicologists, pathologists, technicians, analytical chemists, research clinicians and students.
