Validation & Verification (Performance Parameters used to determine if…
Validation & Verification
Performance Parameters used to determine if a method is fit
can the results be reproduced
how close to the value
the accuracy of its measurement
rate of change of a response against the conc
the degree to which the results are unaffected by minor change
Range in which the calibration equation replies
Three types of test methods
published by international or national standards (Standard Australia or ISO)
Methods developed by individual scientists, and published in peer reviewed scientific journals. Methods are published by a manufacturer.
In-house or Laboratory developed methods:
developed by the laboratory itself to suit its own particular needs.
is the process of assessing the ability of a method to obtain a result, determine the conditions under which results can be obtained, determine the limitations, find any critical aspects that must be maintained.
Must happen prior to the introduction of the method
is the process of assessing the lab's capability to perform a Standard method against the documented performance characteristics. Also applies to published methods. Ensures the competence of laboratory staff.
Standards & Technical Notes that guide
laboratory must validate non-standard methods, their intended scope, amplification and modification of standard methods and if they are fit for use
identify critical aspects, may be validated by comparison to other methods, validation must be conducted by the scientific community, records must be avaliable.
Technical Note 17:
validation must identify critical aspects of a procedure which must be carefully controlled. Must be validated by comparison, and against materials of known characteristics.