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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
Validation is the confirmation by examination and the provision of objective evidence that the particular requirements for a specific intended use are fulfilled. It is a process of determining how well one system replicates properties of some other system. In other words, any comparison between a representation of a system and specified criteria.
those tests/methods and instruments must be validated before diagnostic use to ensure reliable results for patients, clinicians or referring laboratories and their
quality must be maintained throughout use. In other words, the laboratory must demonstrate that their tests/methods are fit for the intended use before application to patient samples.

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.
Validation provides confidence that the outputs of the model conform to the reality in the required range. It is also a regulatory requirements for the Laboratory to demonstrate that prior to reporting patient test results, it can obtain the performance specifications for accuracy, precision, and reportable range of patient test results, comparable to those established by the manufacturer.

5. Validation requirements
Qualified and calibrated instruments
Documented methods e.g. protocol manuals
Reliable reference standards
Qualified analysts
Sample integrity
Manufacturer’s package inserts
Diagnostic validation is a formal requirement of accreditation standards, those tests/methods and instruments must be validated before diagnostic use to ensure reliable results for patients, clinicians or referring laboratories and their quality must be maintained throughout use. In other words, the laboratory must
demonstrate that their tests/methods are fit for the intended use before application to patient samples

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
As part of the planning the Laboratory shall assign the responsibility who shall be responsible for carrying out the validation process and deciding the outcome.
The planning shall also involve the documented detailed description of the validation procedure to ensure its proper performance and repeatability. This ensures that all laboratory personnel that are qualified can do just as the method with comparable results.

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
When examination procedures have been validated by the method developer (i.e., the manufacturer or author of a published procedure), the laboratory shall obtain information from the method developer to confirm that the performance characteristics of the method are appropriate for its intended use. When changes are made to a validated examination procedure, the influence of such changes shall be documented and, if appropriate, a new validation shall be carried out.

8. Basic Components of Method Validation
Accuracy
Precision
Repeatability
Reproducibility
The approach in method validation is to perform a series of experiments designed to estimate certain types of analytical errors, e.g., a linearity experiment to determine reportable range, a replication experiment to estimate imprecision or random error, a comparison of methods experiment to estimate inaccuracy or systematic error, or interference and recovery experiments to specifically estimate constant and proportional systematic errors (analytical specificity), and a detection limit experiment to characterize analytical sensitivity

9. Basic Components of Method Validation
Range Validation and Verification
Linearity and range
Specificity
Sensitivity
Limit of detection
Limit of quantification
The approach in method validation is to perform a series of experiments designed to estimate certain types of analytical errors, e.g., a linearity experiment to determine reportable range, a replication experiment to estimate imprecision or random error, a comparison of methods experiment to estimate inaccuracy or systematic error, or interference and recovery experiments to specifically estimate constant and proportional systematic errors (analytical specificity), and a detection limit experiment to characterize analytical sensitivity

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.