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Method Development and Validation

Method Development and Validation

Validation of an analytical method is mandatory for all regulatory submissions and demonstrates the scientific accuracy of the data collected and analysis.

The validation practice demonstrates that an analytical method measures the correct substance, in the correct amount, and in the appropriate range for the intended samples. It allows the analyst to understand the conduct of the method and to establish the performance limits of the method. 

 

JRF Global has various standard operating procedures (SOP) to perform method validation. JRF’s GLP certified calibration laboratory ensures usage of calibrated instrumentation and our top-notch QA team ensures full GLP compliance of the protocol, corresponding operating SOP and the developed method. Our test facility management ensures a well-developed and documented test method and an approved protocol prior to the execution of any validation experiments. The protocol is a plan that describes which method performance parameters will be tested, how the parameters will be assessed, and the acceptance criteria that will be applied.  Finally, samples of the API or drug product, placebos, and reference standards are needed to perform the validation experiments.

 

The following performance parameters are used for method development and validation.

 

 

PARAMETERS DEFINITION
Accuracy Assessment of the difference between the measured value and the actual value
Precision Measure of the repeatability for multiple measurements on the same sample
Specificity Ability to assess the analyte in the presence of other components
LOD The lowest amount of analyte that can be detected accurately
LOQ The lowest amount of analyte that can be quantified accurately
Linearity & range The proportionality of the measurement to the concentration of the analyte within a specified range
Robustness A check of the effect of deliberate small changes to the method on the results

 


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