Importanţa principiilor de bună practică de laborator în asigurarea calităţii studiilor preclinice

Abstract

Background: The institution, which studies the safety of chemicals, biotechnological substances and nanotechnology products, should conduct researches in accordance with the principles and rules of GLP (Good Laboratory Practice). This standard establishes principles of good laboratory practice for application in non-clinical studies of substances contained in the medicines, pesticides, cosmetic products, veterinary drugs, food and feed additives, and industrial chemicals. GLP rules is a concept of research management, including the organization, preparation and conduct of the study, activity monitoring, obtaining and documenting data, concluding the report. Compliance with GLP principles in the conduct of studies is a mandatory requirement imposed by national regulatory agencies to determine the safety of chemical compounds and other substances related to the protection of human health and the environment. The issue of quality assurance of drug substances is particularly relevant during the authorization process of drugs. Application of standards is an important issue not only in the production of drug substances, but also in preclinical research and clinical studies. Application of GLP rules in research institution is guaranteed by a center quality assurance program, as well as by the institution’s management control and independent audit. Conclusions: GLP implementation in biomedical research centers of the university in the country will lead to proper management of preclinical laboratories and therefore will increase the credibility of scientific results at international level.