Deal qualification for Pharmaceutical

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hi this is paul palmer i thought i'd talk a little bit more today about the qualified person as i keep getting quite a lot of questions about about the topic on the topic so what does it mean to be a qp not how do you become a qp because that's you get yourself a degree you join one of the professional bodies you take a two-year course take a verbal um exam and then provided you've got the uh right experience you can you're eligible to be a qp now that's the gb route um there's different routes depending on which country you're in so the majority of europe it's you have to be a pharmacist um as your base degree some of them require you to be a masters an msc in pharmacy and some of them will allow you to then go straight on and be a deputy qp or a nominated qp with somebody else on the license and you just have an agreement between you and them but i quite like this picture as the qp as the judge because a lot of people in the family industry think well it'll be all right if the qp says if the qp says it's all right rather than taking responsibility for their own actions and ensuring that the product has the right quality safety and efficacy to be able to sell it now okay the qp will make a decision but if you give him all the supporting evidence and all the facts all the additional tests that might be needed then it makes this decision easy and it can release it in a timely manner the problem comes as a qp when they don't give you the facts when they don't give you the information so i'll give you an example i had a problem with a site where they they had mold they'd found mold within the facility and i was asked to say well is it does it impact the product or not i said well where was it found oh it's in the great sea okay so it's two rooms away from um the filling line does it impact the process well i don't know well that doesn't help me make a decision does it what's the likelihood what's the risk of that mold impacting the product well we don't know well have you identified the mold oh no not yet we just know that we found one well wouldn't that be a good idea yeah do the identification is it a spa farmer i don't know well if they can tell you that there's no rest of the product because it was found in an area maybe it was found in the changing room only and it was found uh on exit clothing or it was found in the rubbish bin on the side on the rubbish bin or it was found in a location where there's a relatively low or zero chance of it impacting the product then you've got an easy decision but if they then say oh well it was found at the point where we lured up the vials into the machine to be able to go through the processing stage and filling well then you need to think well is there a higher risk what happened with the other environmental test results what can you give me what information have you got available for all the rest well yeah we had a couple of other excursions and we had this problem and that problem well it's easy you've got a reject decision straight away or no this was an isolated incident we've never seen it before and we believe we've identified the source as blah blah blah because this is based on the raw material the raw material sterilized before use so we believe it was just from blah blah blah so there's no risk to the product no risk of the patient then you've got an easy decision so the judge isn't really the qp the person that assesses the facts that assesses the information says well there is no risk to the patient well they're the one that's giving you the information that allows you to support them not judge them support them with the facts and actually sign off on a decision that somebody else could have recommended so when you're talking to the qp don't just say oh well i've got this problem what do i do go with a solution go with the answer to your question that you believe is correct make sure you've got all the support and influence ready and then it won't have to be the judge and jury i'll just be able to um accept what you've said ratify it sign it off say yeah off we go the worst thing for a qp is somebody comes in with a problem that there's no potential solution for and he has to identify all the extra testing and information that you need before you can go away and do it and then you come back with all that extra information you find some more problems because you haven't done a full detailed investigation and identified the root cause or maybe several potentially assignable root causes and then looked at what you can do about it and what the risk is to the products to the patient and what mitigates that risk based on the future processing of the product well wouldn't that be much easier for the qp to release your pharmaceutical product if he's got all the information you can sign on the bottom line but if it doesn't it's gonna ask you to go away and deal with it okay that's it for me for today it's paul palmer i'll talk to you soon