This teaching material has been made freely available by the KEMRI-Wellcome Trust (Kilifi, Kenya).

1. www.GlobalHealthLaboratories.org 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.

2. VALIDATIONS GCLP TRAINING COURSE KEMRI-Wellcome Trust Research Programme

3. What is validation? • Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled

4. Purposes of Validation : • To quantifiably characterize system performance • To assess potential for error • To identify method-to-method differences • To meet regulatory guidelines • Increase confidence that the output conform to reality in the required range.

5. Validation requirements • Qualified and calibrated instruments • Documented methods e.g. protocol manuals • Reliable reference standards • Qualified analysts • Sample integrity • Manufacturer’s package inserts

6. Validation Plan • Statement of purpose and scope • Responsibilities • Documented test method • List of materials and equipment • Procedure for the experiments for each parameter • Statistical analysis • Acceptance criteria for each performance parameter

7. When to Do Method Validation Studies: • When considering purchasing a new system • When placing a new system into service • At regular intervals to assess on-going system performance • When troubleshooting questionable system performance

8. Basic Components of Method Validation • Accuracy • Precision • Repeatability • Reproducibility

9. Basic Components of Method Validation • Range Validation and Verification • Linearity and range • Specificity • Sensitivity • Limit of detection • Limit of quantification

10. Basic Components of Method Validation • Range Validation and Verification • Reportable Range • Critical Limits • Analytical Measurement Range • Clinically Reportable Range • Calibration Verification / Linearity • Reference Range Studies

11. Validation Good Practices • To select analytical procedures suitable for answering the analytical questions. • To perform the selected test in • Traceable manner • According to clear and transparent procedures under proper conditions.