Title :

Implementation of Good Clinical Laboratory Practice in an Immunology Basic Research Laboratory: The KEMRI-Wellcome Trust Research Laboratories Experience.

Abstract :

Objectives: Good Clinical Laboratory Practice (GCLP) is a standard that ensures quality and reliability of research data by adopting the principles of Good Laboratory Practice and Good Clinical Practice. Even though implementing a quality system in a basic research laboratory is still a contentious issue, it ensures that the research data are accurate, valid, and reliable. GCLP implementation requires proper documented procedures and safety precautions to achieve this objective.Methods: This article describes the Kenya Medical Research Institute (KEMRI)-Wellcome Trust Research Laboratories experience in the implementation of GCLP guidelines in a laboratory conducting basic research.Results: The laboratory managed to implement GCLP elements that could be applied to a basic research laboratory, such as standard operating procedures, equipment management, laboratory analytical plans, organization, and personnel. The laboratory achieved GCLP accreditation in October 2015.Conclusions: The methodology, suggestions, and comments that arose from our experience in implementing GCLP guidelines can be used by other laboratories to develop a quality system using GCLP guidelines to support medical research conducted to ensure the research data are reliable and can be easily reconstructed in other research settings.

Authors :

Gumba, H., Musyoki, J., Mosobo, M., Lowe, B.

PubMed link :

Journals :

American Journal of Clinical Pathology. 2018