What is method Development and Method validation? Whether QC experience is suitable for that role?
In general Method development activity carried out by AR&D.
The main aim of the method development team is to develop the analytical procedure for the analysis of particular drug substance or product.
In small scale of industries, method development and validation activities carried out by QC staff.
After development activity the method has to be validated by the same or QC department, to confirm its efficiency and suitability of the test method.
Before starting of the method validation, protocol to be defined and report the results.
QC persons also can do the method development, by using the technical knowledge regarding the peaks separation, elution, column and mobile phase selection along with system parameters to develop the suitable method.