While determining the acceptance criteria for different products I used the most stringent criteria among three criteria:
a) 0.1 % dose criteria (safety factor)
b) 10 ppm criteria
c) visual cleanliness.
My result shows that for many products visual cleanliness was the most stringent criteria. Now, my concern is whether I can use the visual cleanliness (qualitative testing) as sole acceptance criteria for validating the cleaning procedures and can exclude the analytical testing (quantitative testing) for residue analysis. Is it mandatary to quantify the residue with analytical testing for showing the evidence that my cleaning procedure is effective to remove the residue to accepatble predetermined level?
Suggestions are welcome.