The Role of The Qualified Person (QP) in GMP.

Role of the Qualified Person:-

In the UK we've quite complicated process. Before we dive into this story about what it takes to be a QP then on. are you able to tell a touch about the roleof the QP especially for the people that aren't from Europe not everybody has these roles it's more a Europe thing. Right, it's considerably a Europe thing and therefore the role of the QP actually comes from quite way back in history back within the late 50s early 60s we had the issue and legislation was introduced to manage the medicines. so it started there from the UK due to some tragic event. unfortunately yes it's called the The Devonport Incident which started somelegislation within the EU in 1975 which legislation led to the need of authorisation of web sites of manufacture and introduced the concept of somebody who would be overall liable for the control and quality of the medicines and this wording within the legislation may be a suitably qualified person so if you are an English speaker or non-english speaker the title of this role may be a bitstrange a professional person everybody is qualified in what they are doing . But the wording of the legislation actually led to the title qualified person and the qualified person role it requires some education things and a few experience but essentially we are a gate keeper within the medicines role here within the EU and what we do is we oversee almost the whole supply chain of medicines. we glance at the active ingredients what makes medicine actually work. we glance in the least the inactiveingredients, everything the majority of the drugs .

Some of the items that a QP must oversee.

Almost the whole supply chain

Active ingredients

Inactive ingredients

Controls

Manufacturing

Quality systems

Challenge in Becoming a professional Person:-

testing that happens, we glance manufacture to form sure that it'sconsistent and doing what it says it does and that we actually check out all the systems around that manufacture and that we take that as a holistic whole and with all of the output from laughs and say is that this medicine okay to tend to apatient and if that answer is yes then we'll actually make a signature and that signature is taken to mention which will then continue to patients. 

So what would be the difference between a daily quality manager and a QP then?

 The regular quality manager will have defined responsibilities and that they it may actually, be doing an equivalent thing because the QP but the regular quality manager doesn't have formal sign-off from the Authority therein country to be able to make that call and sign that document to mention it can go. Only somebody who has been authorized by the regulator of warranty can do so they're basically legally bound and that they are often held responsible if something wrong happens That's absolutely correct. That's why their role is so important so you were also a professional person As within the UK so what does it mean that you interviewed people that wanted to be qualified person and you had to give them a grade or fail or pass? That's exactly right. So in the united kingdom to become a QP you are doing need to pass an assessment before you'repassed on to the MHRA here within the UK to be considered suitable. therefore the assessment panel is, we've three Assessors and you've got to possess an oral . So we ask lots and much of questions and as long as you'll pass that then yes it is a pass/fail it isn't a grade it is a pass/fail. okay, so either you can do it otherwise you can not.

Who should consider becoming a professional Person:-

Certainly, there are people who really enjoy being QPsand those people I would say have a sense of curiosity. We do look forquality professionals but that doesn't mean that other people can't move in to that real me. I've certainly seen a lot of pharmacists, community pharms, just moving into that real. There are minimum standards so you do have to avoid between quality to become a QP  but you can obviously join into quality and what find fascinating is that the role is so broad-based that you can have lots of different experience to come into it but the type of people that really do mak every good QPs are those who are interested in lots of different things.You do need to have a curiosity about what's going on, you need to be able to look into lots of things, and you need your problem solver. You need to love to see the big picture because as QP you need to understand and love each part of this chain of manufacturing chain the supply chain you really need to understand because in the end people come to you with the questions. People do come to you with questions absolutely and I always say that the QP doesn't actually have answers. The QP asks further questions to clarify and generally whoever comes to you with the question does actually have the answer them selves but the QP will help them and they will clarify the picture and let them see what the risks are with various options. So it's an oversight and this person also should really be a good leader in the sake that he doesn'tjust order things he needs to listen and help other people to understand the problems. Leadership is huge very often certainly in the UK the QP is not in a leadership or a management position but they have to lead in many examples and areas. So for example if there is a potential quality issue where the product needs to be recalled then the QP starts to take charge of that situation and they start to lead that of people who are discussing that and that may have some very very senior people in the organization but the QP is generally the decision-maker inthat situation- are we going to recall the product, are we going to issue awarning to patients and that does need a lot of leadership.