Guidelines for Laboratory Quality Auditing

1. Auflage 1992
ISBN: 978-0-8247-8784-4
Verlag: CRC Press

Buch, Englisch, 426 Seiten, Format (B × H): 157 mm x 235 mm, Gewicht: 767 g

Reihe: Quality and Reliability

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.

Zielgruppe

Professional Practice & Development

Autoren/Hrsg.

Singer, Doanld C.

Upton, Ronald P.

Fachgebiete

• Interdisziplinäres Wissenschaften Wissenschaften: Forschung und Information Forschungsmethodik, Wissenschaftliche Ausstattung
• Wirtschaftswissenschaften Betriebswirtschaft Bereichsspezifisches Management Produktionsmanagement, Qualitätskontrolle

Inhaltsverzeichnis

"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) "

Über Autor(innen)

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