RAL smaller than NOISE

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Good morning,

We are calculating our RAL for a cleaning validation and our RAL obtained is much smaller than the cuantification limit for HPLC, the equipment noise is higher. Shall we use then the 10ppm for our MAR and then recalculate the MAR (maximum acceptance residue)? Or the problem is that HPLC is not a good method in our case? Is it possible to use only the TOC method?:confused

Thanks in advance

2

Dear Anuki
Don’t change your contaminant limit based on the ability of your testing equipment. But, you need to change your test equipment based on your contaminant limit. So, better you should go for higher sensitive test method, like TOC. If you product (contaminant) is less potent, then you can consider 10 ppm as your contamination limit