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Good laboratory practice regulations /

Good laboratory practice regulations / edited by Sandy Weinberg. - Second edition, revised and expanded. - x, 294 pages : illustrations ; 24 cm. - Drugs and the pharmaceutical sciences ; v. 69 .

Previous ed. edited by Allen F. Hirsch.

Includes bibliographical references (p. 267-287) and index.

Historical perspective; FDA/GLP regulations; EPA and foreign country GLP regulations; implementing GLPs in a non-GLP analytic laboratory; GLPs in an automated laboratory; computer system validation; the FDA's GLP inspection programme; the GLPs - the cybernetic necessity.


This work covers all aspects of the Food and Drug Administration's Good Laboratory Practice regulations and techniques for implementation. This edition includes general knowledge on computer system validation and details on implementing GIPs in an automated laboratory.

0824793773 (alk. paper)

95010741


Medical laboratories--Quality control.
Medical laboratories--Law and legislation.
Biological laboratories--Quality control.
Biological laboratories--Law and legislation.

R860 / .G66 1995

574.072 / G