Guidelines for Laboratory Quality Auditing

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

• "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) "

". . .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