Implementation of Good Clinical Laboratory Practice in an Immunology Basic Research Laboratory: The KEMRI-Wellcome Trust Research Laboratories Experience. Issue 3 (18th October 2018)

• Record Type: Journal Article
• Authors: Gumba, Horace; Musyoki, Jennifer; Mosobo, Moses; Lowe, Brett
• Is Part Of: American journal of clinical pathology. Volume 151:Issue 3(2019)
• Page Start: 270
• Page End: 274
• Publication Date: 2018-10-18
• Subjects: Good Clinical Laboratory Practice (GCLP) -- Quality assurance -- Quality system; Diagnosis, Laboratory -- Periodicals; Pathology -- Periodicals; 616.07
• DOI: 10.1093/ajcp/aqy138
• Languages: English
• ISSNs: 0002-9173

Abstract

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.