The positioning of the Qualified Person (QP) within the organisation


In previous posts we have looked at the Roles and Responsibilities of the 3 Key Personnelrequired by EU GMP, namely the Head of Production, the Head of Quality Control (QC) and the Qualified Person (QP).  In this post we look at the organisation of these people within the business.  It is in the spirit of GMP that these roles are taken by people who are permanent employees of the organisation in full-time roles (EU GMP Chapter 2.3), but does that mean you need to employ three different individuals?  Can, for example, you be the Head of QC and also be the Qualified Person?  This article looks into this.

At a minimum you must have two individuals, one occupying the role of Head of Production and the other occupying the role of the Head of QC.  The reason for this is that it states in EU GMP Chapter 2.3 that “the heads of Production and Quality Control must be independent from each other”.  In other words, they cannot be the same person.

So what then for the Qualified Person (QP)?  GMP does not state where they should be positioned in the organisation. This raises some questions:

Is it possible for the QP to also be the Head of QC?

The answer to this is yes.  The Head of QC can also undertake the roles and responsibilities of the QP.  Most people I talk to about this are reasonably comfortable with this idea, as long as the person is not overloaded with responsibilities.

Is it possible for the QP to also be the Head of Production?

The answer to this is also yes.  However, people do often feel a little bit uncomfortable about this idea.  It is possible, but as we have said, you must have a Head of Quality Control who is independent of Production.  It has to be said that it is rare for the QP to also be the Head of Production, but it is possible.  One way in which you may feel more comfortable about this is remembering the principle role of the QP at batch release – to ensure that that batch was made to licenced conditions and GMP, and if anything goes wrong – the QP is accountable.  Couple this idea with the old saying “if you want something done properly – do it yourself”.  You could from this then make the argument that if you were responsible for making the batch (because you are the Head of Production) then you should be pretty sure it was made to licenced conditions and GMP!  So – it is possible for the QP to also be the Head Of Production, but this is rare.

Is it possible for the QP to also be the Head of Quality Assurance?

The answer to this is yes – and this is normally the case.  Most pharmaceutical manufacturing sites establish a QA (or Quality) Department and you often find that the QP is the head of that department or, if there is more than one QP, then they work in the QA (or Quality) Department.  The Quality Department can include both QA’s and QC’s roles and responsibilities.

This is generally what happens here in the UK, but arrangements for the QP do differ somewhat across Europe.  Please feel free to comment below.

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