Abstract

Good laboratory practice (GLP) is a quality system in which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported. The purpose of GLP is to ensure the adequate environment and the satisfied quality, integrity, traceability, and reliability of safety data through the implementation of well-established quality management system for safety assessment for human and environment. GLP was first introduced officially in 1972 New Zealand Testing Laboratory Act; however, the formal regulatory concept of GLP was created by U.S. Food and Drug Administration in 1978. Other two representative GLP regulations are GLP issued by the U.S. Environmental Protection Agency and GLP harmonized by the Organization for Economic Co-operation and Development. These three GLP regulations are different in scope as well as the definition of nonclinical laboratory study. GLP system shares common principles with laboratory accreditation quality system in a large sense, which differs significantly from accreditation system with respect to the quality assurance system and regulatory purpose. In order to promote the market approval procedure for new products, more and more national regulatory authorities have signed the Memorandum of Understanding or Mutual Recognition Agreement on GLP. Good statistic practice plays the key role in many aspects such as scientific and reliable study design, sampling plan, data analysis, instrument calibration, and decision rules.