QSP Test Method and Method
Calibration
Method selection - answer Statement of persons responsible for selecting methods
adopted within SOP. That such methods are based on published international, national
and/or regional standards or deemed for fit for testing criteria.
Analytical Methods - answer Index of all SOPs and related procedures implemented by
lab.
Validation - answer-SOPs and related procedures are validated for control samples
-Documentation of performance criteria for accuracy, recovery, precision, detection
limits, calibration, and linearity.
Calibration
Method selection - answer Statement of persons responsible for selecting methods
adopted within SOP. That such methods are based on published international, national
and/or regional standards or deemed for fit for testing criteria.
Analytical Methods - answer Index of all SOPs and related procedures implemented by
lab.
Validation - answer-SOPs and related procedures are validated for control samples
-Documentation of performance criteria for accuracy, recovery, precision, detection
limits, calibration, and linearity.
