Limit calculated or 10ppm

Hi all,

Please, I need your help again: what happen when my MACO is such low value that i cannot reach it with my analitical method (HPLC, TOC? What shall I do? accepting the MACO as 10 ppm or the first value of the next worst case that I can reach? What is accepted by EMEA and FDA?

Thanks in advance folks!

I would say re-evaluate your MACO because there are very high toxicity substances that have limits detectable by HPLCs. You may also increase your swabbed area or your batch size of the next product.

You could adjust your analytical method to meet your limit by re-validating. Repeat the linearity and Range to comply with the lower value. Are you sure your MACO is correct? What is your recovery analytical limit?

Please, please stop using the 10 ppmā€¦EMA just published a draft guidance (the comment period just closed) where they clearly state that 10 ppm and 1/100th of a low clinical dose are not acceptable and toxicological and pharmacological data must be used to set a threshold value. Here is the link