History of FDA good laboratory practices

Abstract

The United States Food and Drug Administration (FDA) requires nonclinical studies of new drugs, food additives and chemicals to predict their safety and potential efficacy in humans. The significance of the information gained from these studies requires that they be conducted according to sound scientific principles and with strict attention to quality assurance and quality control. Human health and safety are dependent upon the decisions made from these studies. The discovery of the lack of companies' adherence to these principles led to the development of the good laboratory practice (GLP) regulations, the driving force behind the quality of nonclinical laboratory studies. As the 25th anniversary of the publication of the regulations approaches, a description of the events leading to the proposal of the GLP regulations provides understanding about their significance and the importance of their use in assuring the quality and integrity of nonclinical safety data. Copyright © 2003 John Wiley & Sons, Ltd.

Implementation of Good Laboratory Practices (NIT-DICLA-035, Inmetro) in a technological platforms network: the Fiocruz experience

“…GLP is a quality system concerned with the organizational process and the conditions, under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported [17].…”

“…The positions defined in the GLP guideline are: test facility management, test site management, sponsor, study director, principal investigator, study personnel, and archivist [17]. To this end, an organizational structure was defined by aligning the existing responsibilities of platform personnel with the positions created by GLP implementation.…”

“…However, there are some guidelines in worldwide circulation, such as ISO/IEC 17025, used in laboratories for trials and/or calibration [15], ISO 15189, utilized in clinical analysis laboratories [16], and Good Laboratory Practices (NIT-DICLA-035/GLP), applicable to non-clinical research [17] that can be employed with a guarantee of success, considering some adaptations necessary for R&D activities.…”

Uncertainties of testing methods: What do we (want to) know about carcinogenicity?

“…This decision prompted the development of international guidelines and the implementation of Good Laboratory Practices (Baldeshwiler, 2003).…”

Food and Drug Administration: Nonclinical Program and Pharmaceutical Approval

“…The Good Laboratories Practice (GLP) regulation (21CFR Part 58) was codified in 1978 in response to poor practices by a few laboratories involved in the conduct of preclinical safety studies (Baldeshwiler, 2003). Since that time, many regions have developed GLP regulations.…”