Cleaning Method (HPLC) validation completed for one of our product by considering specification limit as 0.4ppm unfortunately actual spec limit 4ppm). Now we want prepare specification with limit 4ppm, MOA same as done in method validation.
for this, whether we have to perform again method validation by considering specification limit 4ppm ????????????? Or not required.
the same method validation can support the 4ppm specification limit????
Thanks in advance...............