REGULATIONS AND STANDARDS IN GOOD LABORATORY PRACTICES FOR CELL CULTURES: A REVIEW

Nuñez Diaz J.; Coca Málaga E.; Gonzales Molfino M.; Chavieri Salazar A.; Gonzales Figueroa H. · Revista de la Facultad de Medicina Humana (2025) · DOI: 10.25176/rfmh.v25i1.6721

Resumen

Introduction: Good Laboratory Practices (GLP) in cell culture are essential to ensure the quality and reproducibility of results in scientific and biomedical research. This review aimed to comprehensively analyze the regulations and standards related to GLP in the management of cell cultures, emphasizing their importance for the quality and reliability of scientific findings. A literature review was conducted, encompassing 33 articles published between 1994 and 2023 in academically relevant databases such as Scopus, ProQuest, ResearchGate, ScienceDirect, Springer, among others. Search terms included "Good Laboratory Practices," "GLP," "regulations," and "cell cultures," with specific selection criteria applied. Extracted data covered regulatory frameworks, governing bodies, and areas of application. The findings highlight that guidelines issued by organizations such as the Organisation for Economic Co-operation and Development (OECD), the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA) are essential for the proper implementation of GLP in laboratories working with cell cultures. Furthermore, critical aspects such as precise documentation of procedures, continuous staff training, and implementation of quality and sterility control measures are addressed. The review concludes that the rigorous application of GLP is crucial for ensuring reproducibility, quality, and safety of results, as well as for compliance with regulatory standards—thereby strengthening scientific integrity and fostering advances in biotechnology and biomedicine.

Instituciones: Universidad Ricardo Palma