Chromatography Forum

Hi All

We have been requested to do method verifications on Inactive Pharmaceutical ingredients (IPI's) e.g Startch maize, Povidone, mag stearate and ethanol. The methods for these IPI's are based on the Ph. Eur and USP Pharmacopoeia.

Do you think it is necessary to do method verification on IPI's? Could we not do comparative testing i.e. compare our results to the supplier's results. Surely, this should be sufficient to show that we are able to execute the Pharmacopoeial methods. Our current practice is to do method verification on all Active Pharmaceutical Ingredients (API's). I think doing method verification i.e. specificity, precision etc. is "overkill" for IPI's.

Any comments/suggestions would be greatly appreciated.

Regards
Mike

Who is asking about inactive materials? Pointy-haired boss like in Dilbert or a customer?

Stuff like starch maize and Mg stearate are not pure materials, so I hope you have quite a few years until you retire, would be challenging.

Morning All

thanks for your comments. We manufacture Drug Product for a multinational company and they have requested us to verify Ph Eur/USP methods for the IPI's.

Regards
Mike

We manufacture Drug Product for a multinational company and they have requested us to verify Ph Eur/USP methods for the IPI's.

I'd ask the customer/potential customer for guidelines like requirements for agreement/recovery/repeatability they require. Guidelines for method validation are pretty spelled out, but for verifications there is much more gray area.