Guidelines for Laboratory Quality Auditing

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.

List 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) "

About the author

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

Product details

• Authors: Singer, Doanld C Singer, Doanld C. Singer, Donald C Singer, Ronald P Upton, Ronald P. Upton, Upton Ronald P.
• Publisher: Taylor and Francis
• Languages: English
• Product format: Hardback
• Released: 23.11.1992
• EAN: 9780824787844
• ISBN: 978-0-8247-8784-4
• No. of pages: 426
• Weight: 960 g
• Series: Quality and Reliability
• Subjects: Natural sciences, medicine, IT, technology > Technology > Mechanical engineering, production engineering; BUSINESS & ECONOMICS / Production & Operations Management, BUSINESS & ECONOMICS / Quality Control, SCIENCE / Scientific Instruments, SCIENCE / Laboratory Techniques, Scientific equipment, experiments & techniques, Production & quality control management, Scientific equipment, experiments and techniques, Production and quality control management