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Validation/ Method Validation - Coggle Diagram
Validation/ Method Validation
Why validation?
To make sure your result is trusted and is in part of ISO
Validation is the process by which it is established, by laboratory studies that the performance of the procedure meet the requirements for the intended analytical application
Verification of method
Critical instruments replaced
New reagents
changes of lab premises
New chemists
Validated method that not been used for long time
Parameter of method validation
Accuracy
Closeness of true Values
Compare with standards
min 9 determinations over min 3 concentrations
Reported as percent recovery
Precision :
min 9 determination over min 3 conc
Expressed in terms of SD, relative SD and CI
Checking can be varied in days, analyst,equipment, etc
Specificity
ability to access unequivocally the analyte in the presence of impurities, degradation products and matrix components
Limit of Detection
the lowest amount of analyte in a sample that can be detected
expressed as the concentrations of analyte
Non instrumental & instrumental procedures
Limit of quantitation
lowest amount of analyte that can be determined with acceptable precision and accuracy
calibration
operating range
interval between upper and lower levels of analyte
sensitivity
ruggedness
Different conditions but same methods will give the same results
Different laboratories, Analysts, Instruments, Reagents, Days
robustness
When do the analysis, you must get the same precision, accuracy of results every time you do the methods
Linearity
Measurement that can take in linear form.
by appropriate statistical methods
r^2 = 1 (most accurate)