USP India’s Post

Transcript

I mean normally excipients are considered in the last part of the pyramid. All focus is on API product and then you come to pyramid last of excipients. Which somehow I feel is little unfortunate. When you talk about drug product it would contain at least when we say RM you classically have to classify them as excipient. So you have one API and four exceptions and the. Eyes focus is always on API and then what happens to CPS is something which is unknown factor. Now is industry in general excipients per se are are sensitive about it. Definite answer is yes. But you as an end product user, how do you? Really understand that whether my supplier or any CP and supplier is really conscious and aware about this as a problem. Now with one formulation containing Phi and you having a store of excipients, it's very difficult to understand. And are there common guidances? So when we talk about APIs, there are many guidances available. I would say there is one body which is doing really good and that is called as International Pharmaceutical Excipient Council. So most excipient manufacturers take cue from this. Now is this body very proactive in doing this? Yes. So we had seen different stages of problem areas or new definitions that come as problem. So it started with element, elemental impurities, impurities in the excipients and lately, very lately lighter, so mean. Does IPEC as a body of excipient have a position on it? The answer is yes. So what does it normally do for all the excipient manufacturers put together as consortium? They really work very closely with USB, they work very closely with FDA's and the European agencies. And then there is a consciousness on how to address this proactively so. The guidance is there, the benchmark is there, the seriousness is there. Now is it equal among all? That is something which which is something which will take some time from excipient manufacturer to another exception manufacturer, it will take some time. But they say classically for nitrosamine, is there a risk assessment based approach already existing? And is it common from 1 manufacturer to other? You really need answer which has to speak same language, same science. The answer is yes. So if you go to XP and manufacturer, you really need to talk to them and get their understanding on risk assessment. Which really defines whether they understand it and if they understand it. Normally the answer is yes, you as is and manufacturer would also get solution because your supplier really understands it.