The validation of an analytical method demonstrates the scientific accuracy of the measurement or characterization. It is mandatory for all regulatory submission processes
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.
procedures (SOP) to perform method validation. JRF’s GLP certified calibration laboratory ensures usage of calibrated instrumentation and QAU ensures the GLP compliance of the protocol, corresponding operating SOP as well as the developed method. 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 API or drug product, placebos, and reference standards are needed to perform the validation experiments.
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PARAMETERS |
DEFINITION |
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Accuracy
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Assessment of the difference between the measured value and the actual value |
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Precision
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Measure of the repeatability for multiple measurements on the same sample |
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Specificity
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Ability to assess the analyte in the presence of other components |
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LOD
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The lowest amount of analyte that can be detected accurately |
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LOQ
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The lowest amount of analyte that can be quantified accurately |
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Linearity & range
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The proportionality of the measurement to the concentration of the analyte within a specified range |
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Robustness
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A check of the effect of deliberate small changes to the method on the results |
Equipment used:
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HPLC with several array of detectors
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GC-MS
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LC-MS
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HPLC-MS/MS
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ICP-OES
Services available at following locations: