A highly detailed guide to the principles and specifics of quality management needed to ensure that studies of chemical safety produce accurate and meaningful results. Focused on the management of both the laboratory and the individual studies it conducts, the book stresses the need to establish and follow formal standard procedures for virtually every laboratory practice that can influence the quality of study results. The objective is to help laboratory managers and staff think through all possible sources of error and plan appropriate measures for their control. Details range from a list of the types of records that must be kept to a description of the precautions needed to make certain that chemicals used for cleaning or pest control in animal rooms do not interfere with the study. The book has three chapters. The first provides a guide to the principles of management and organization required for quality assurance, stressing the importance of making quality assurance an itegral part of the entire study process. To this end, readers are given advice on the selection and training of personnel, the use of inspections and audits, the design of facilities, the maintenance and calibration of equipment, and the formulation and use of written standard operating procedures. Other sections give detailed advice on the quality management of specific laboratory routines and procedures, moving from the preparation of the study plan, through the characterization of test, control, and reference substances, to the reporting of results. The second chapter explains how quality management can be applied to procedures for handling animals at all stages of a toxicity study, from the shipping and receipt of animals to the transfer of tissues and specimens to archives. The final chapter covers the quality control of studies designed to measure the presence of chemicals in humans and the environment, and to monitor the extent and effects of exposure.

eng (with summaries in fre and spa, rus) rus.

WHODOC

WHO monograph

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