Good Laboratory Practice. Part 1. An introduction

• Autores: Richard C. Wedlich, Agata E. Libera, Amanda Pires, Matthew T. Therrien
• Localización: Journal of chemical education, ISSN 0021-9584, Vol. 90, Nº 7, 2013, págs. 854-857
• Idioma: inglés
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• Resumen

  • The Good Laboratory Practice (GLP) regulations were put into place in 1978. They establish a standard of practice to ensure that results from the nonclinical laboratory study reported to the U.S. Food and Drug Administration (FDA) are valid and that the study report accurately reflects the conduct of the study. While the GLP regulations promulgate standards of laboratory conduct, for example, use of qualified personnel, instrumentation, and analytical methods, they also create a need to properly and thoroughly document such conduct. When this is done, it is easy to reconstruct and audit the study at a later date. Ultimately, the laboratory conduct in any particular study is compared to the FDA’s expectations, which evolve over time within the framework of these regulations, thereby moving the entire pharmaceutical industry forward. Yet, few people learn about these GLP standards before entering the industry. It is simply a matter of time before American colleges and universities respond to a pharmaceutical industry need and introduce GLP to undergraduates.