Standard Article

Quality Assurance in Toxicology Studies

Methodology

  1. J. Rodney Pateman CBiol, MIBiol, DipRQA

Published Online: 15 DEC 2009

DOI: 10.1002/9780470744307.gat049

General, Applied and Systems Toxicology

General, Applied and Systems Toxicology

How to Cite

Pateman, J. R. 2009. Quality Assurance in Toxicology Studies. General, Applied and Systems Toxicology. .

Author Information

  1. SafePharm Laboratories Ltd, Department of Quality Assurance, Shardlow, Derbyshire, UK

Publication History

  1. Published Online: 15 DEC 2009

Abstract

Quality systems have been introduced into several areas of toxicology, usually following the discovery of unreliable or fraudulent data. The requirements of regulatory Good Laboratory Practice are described, with some background to those requirements. Other areas of toxicology involved in legal systems are also addressed. The consequences of incorrect data emanating from apparently respected sources are illustrated, and the benefit of implementing quality processes even in the absence of statutory requirement is expounded.

Keywords:

  • quality systems;
  • data integrity;
  • GLP;
  • quality assurance;
  • OECD;
  • UK MHRA;
  • US FDA