Guidelines for Laboratory Quality Auditing / Edition 1

by Doanld C. Singer, Ronald P. Upton

Overview

This single-source reference provides practical guidance for the quality auditing of a chemical or biological testing laboratory-helping to develop or improve quality control and quality assurance programs in order to meet certification standards or pass external-source audits.

Product Details

ISBN-13:	9780824787844
Publisher:	Taylor & Francis
Publication date:	11/23/1992
Series:	Quality and Reliability , #39
Pages:	426
Product dimensions:	6.00(w) x 9.00(h) x (d)

About the Author

Donald C. Singer SmithKline Beecham Pharmaceuticals King of Prussia, Pennsylvania. Ronald P. Upton Consultant Newton, North Carolina.

Table of Contents

"The Need for Quality Control and Quality Assurance in a Laboratory The Regulated Industries Goals of a Laboratory Quality Audit Working Knowledge and Audit Documents Parameters for Evaluation Laboratory Instrumentation: Calibration and Preventative Maintenance Closing Conference, Final Report, and Follow-Up Frequency of Audit Epilog Appendixes Comparison of Domestic Laboratory Standards (FDA, EPA, HCFA) Sample Document for Use in Performing a Laboratory Quality Audit The OECD Principles of Good Laboratory Practice EPA Rules for Environmental Laboratories (State of Illinois Rules and Regulations) Federal Register (FDA): Good Laboratory Practice Regulations for Nonclinical Laboratory Studies Proposed Revision of the Clinical Laboratory Regulations for Medicare, Medicaid, and Clinical Laboratories Improvement Act of 1967 Programs (HCFA) "

Editorial Reviews

". . .provides useful and insightful guidelines for reviewing the structure and function of most laboratories. This book should prove to be an invaluable reference for quality auditors and laboratory managers. The compilation and comparison of the various standards in one volume alone justify the cost. "
—-Quality Progress

From the Publisher

A guide for managers and administrators of chemical or biological testing laboratories, for conducting an audit of the laboratory's quality, and developing or improving quality-control and quality- assurance programs in order to meet certification standards or pass audits by outside inspectors. Discusses the acceptable methods of evaluating the laboratory's output and special areas of concern, and presents the text of relevant federal regulations. Annotation c. Book News, Inc., Portland, OR (booknews.com)

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