Author(s): Huntsinger del W
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Abstract Since the inception of the FDA good laboratory practice (GLP) regulations in 1979, the Organisation for Economic Co-operation and Development (OECD) principles of GLP in 1981 and the finalization of the EPA GLP programme in 1983 there have been recognizable differences among the three compliance programmes. All have been revised since their initial publication, but still there remain differences in verbiage, and in some cases content, among the FDA, EPA and OECD GLP principles, but the end result for each is the assurance that the experimental information generated under each programme is of sufficient quality and integrity to support the reports for the various studies. These differences, while not affecting the data quality, can result in issues when submitting studies globally. An overview is offered of some of the differences that exist between the USA and OECD GLP principles and the challenges global companies face when making regulatory submissions.
This article was published in Ann Ist Super Sanita
and referenced in Pharmaceutica Analytica Acta