Good laboratory practice regulations / edited by Sandy Weinberg. - 3rd ed. - New York : Marcel Dekker, 2003. - x, 244 p. ; 23 cm. - Drugs and the pharmaceutical sciences ; v. 124 .

Includes bibliographical references (p. 229-237) and index.

Historical Perspective, Jean M. Taylor and Gary C. SteinFDA/ GLP Regulations, Wendell A. PetersonApplying 21 CFR Part 11 to the Laboratory Environment, Sandy WeinbergThe Good Automated Laboratory Practices, Gerald J. Whartenby, Paul L. Robinson, and Sandy WeinbergImplementing GLP's in a Non-GLP Analytical Laboratory, Stephanie A. OlexaComputer Systems Validation, Sandy WeinbergThe FDA's GLP Inspection Program, George W. JamesThe Future, Sandy WeinbergBibliographyIndex Table of contents

Summary:
Covers all aspects of the Food and Drug Administration's (FDA), Good Laboratory Practice (GLP) regulations and techniques for implementation. This book details standards and general guidelines for the management of research environment. It examines theoretical principles for anticipating interpretations of GLP in a variety of laboratory settings



0824708911 (alk. paper) 9780824708917

2002035159


Medical laboratories--Quality control.
Pharmaceutical technology.

R850 / .G66 2003

615.19 / GOO 2003

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