19 May 2011
Responsiveness to changes in research funding and shifting global health priorities have led to an increased awareness of the need for Good Clinical and Laboratory Practice accreditation at MRC Unit The Gambia.
Now, following an intense two year drive under the leadership of Clinical Laboratory Manager, Ignatius Baldeh and Quality Manager, Emma Hancox, the Clinical Laboratories have been certified as GCLP compliant. This means that The Unit can demonstrate to sponsors of clinical trials worldwide that the clinical laboratories operate to a standard that assures the reliability, quality and integrity of the work and results generated.
The GCLP accreditation scheme involves the assessment of a clinical laboratory which undertakes the analysis of samples from clinical trials, to assess compliance with the Good Clinical Laboratory Practice (GCLP) standard, as published by the British Association of Research Quality Assurance (BARQA), 2003 ISBN 1-904610-00-5. This is a quality system for laboratories that analyse samples from Clinical Trials in accordance with Good Clinical Practice (GCP) regulations.
In preparation for accreditation, teams at MRC Unit The Gambia worked together to produce procedures and documentation to meet the stringent GCLP criteria embodied in a complete Quality Management System including:
- A policy document describing the clinical laboratories’ objectives
- Quality documentation
- Organisation chart reflecting the relationships of everyone within the department
- Standard Operating Procedures describing controls and work in relation to the labs including equipment and monitoring procedures
- Work Instructions on the performance of specific tasks on the bench.
Accreditation is valid for one year in the first instance. The teams working to maintain this standard will also need to be responsive to changes such as the introduction of new equipment and techniques into the laboratory.
The significance of MRC Unit, The Gambia’s accreditation will boost The Unit’s already important status as a trainer in the country and in the West African sub-region. Unit Director Professor Tumani Corrah said ‘This is a great example of a success story where people from different areas in The Unit have worked together towards achieving a common goal. We are also pleased that our role as a regional training hub for laboratory skills and practices is being strengthened for the benefit of our collaborators.’