Good Laboratory and Clinical Practices: Techniques for the Quality Assurance Professional - Couverture souple

Carson, P. A.; Dent, N. J. H.

Couverture souple

ISBN 10 : 0750619570 ISBN 13 : 9780750619578

Editeur : Butterworth-Heinemann Ltd, 1994

Synopsis

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 * 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 becoming 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. The twenty-seven chapters have been written by a team of recognized world experts. Phillip Carson, PhD, MSc, AMCT, CChem, MIOSH, is Safety Liaison and Quality Assurance Manager at the Port Sunlight Research Laboratory of Unilever. He is a member of the QA (UK) Group's Working Party on Ecotoxicology, of the IChemE's `Loss Prevention Panel' and of the Chemical Industries Association's `Health Advisory Group' and `Exposure Limits Task Force' and past chairman of their Hygiene Working Group. Nigel Dent, a qualityassurance consultant to the pharmaceuticals and chemical industries, was a founder member of the Quality Assurance Group (UK). He is Regional Director (Europe) for the International Society for Quality Assurance and a member of its Executive Council. Mr Dent was formerly Research QA Manager for Hoechst UK Pharmaceuticals and has over 21 years' experience in the pharmaceuticals industry and with contract research organizations.

Détails de l'édition

• Éditeur: Butterworth-Heinemann Ltd
• Date d'édition: 1994
• Langue: anglais
• ISBN 10: 0750619570
• ISBN 13: 9780750619578
• Reliure: Broché
• Nombre de pages: 352
• Coordonnées du fabricant: non disponible
• Personne responsable: non disponible