1. 1 This teaching material has been made freely available by the KEMRI-Wellcome Trust (Kilifi, Kenya). You can freely download, adapt, and distribute this presentation under the conditions that: the Global Health Laboratories and The Global Health Network are referenced; the work is not used for commercial purposes, and any altered forms of this document are distributed freely under the same conditions. www.GlobalHealthLaboratories.org

2. GOALS & OBJECTIVES INTRODUCTION & BACKGROUND GCLP 2 KEMRI-Wellcome Trust Research Programme

3. Course Purpose The Good Clinical Laboratory Practices (GCLP) is a course that is designed for every one with a responsibility in a Clinical Laboratory 3

4. Course Goals & Objectives To internalize the GCLP principles, concept and practices. To empower Laboratory staff (knowledge and skills) which will enable staff to: Manage the Laboratory resources and facilities. Run the Laboratory in more professional manner. Build an effective and efficient compliant laboratory facility to: 1. Provide confidence with Laboratory results 2. Control the Lab processes. 4

5. BENEFITS OF GCLP COMPLIANCE Lab results (research or diagnostic) Reliable, Reproducible & Auditable. The incidences of false negative and false positives is reduces Results are assured to be of highest quality Results are comparable to those in USA, Europe, Australia etc Build Confidence to staff, sponsors and clients Resources are efficiently managed Uniformity and standardization of systems. 5

6. What is GCLP? Set of guidelines that promotes the Quality and Validity of test data 6

7. GCLP OBJECTIVES Ensure Consistent, reproducible, auditable and reliable Laboratory results. Ensure the quality and integrity of data. Allows for accurate reconstruction of experiments performed in the Laboratory. Monitor data quality and allows comparison of test results regardless of performance location. 7

8. Benefits of GCLP Compliant Results are assured to be of the highest quality. Wasting of resources is minimized. The incidences of false positive and false negative is reduced. Results can be compared to other results. The results are assured of Reliability, Reproducibility, Repeatable & Auditable. 8