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

April 24, 2012

Dominic Parry

In previous posts we have looked at the Roles and Responsibilities of the 3 Key Personnel required 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.  What this space for QP training coming from Inspired Pharma training later in 2012.  If you are interested – please get in touch.

4 Comments

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  1. Talal Khayata MSc MPharm GPhC #
    April 25, 2012

    This is very interesting- thank you very much! But suppose you have a QA department and a QP who is the head of this department; where does the Head of QC fit in? and what will his/her relationship be with the QP/QA department?

    • April 25, 2012

      The QP can be the head of the QA department, and you can also have a QC department as well. This would mean that organisationally the heads of QA and QC are at the same level. This is fine.

  2. T.B.Kumar #
    June 12, 2012

    My boss used to say, Quality is the resp[onsibility of Production. QA and QC are just to check whether the product meets the required standards and whether they are manufactured in accordance with GMP. In India, QA persons often think that they are Policemen and they can harass production / Quality control persons to their wimps and fancies by introducing systems which are not possible at that stage without further resources etc.

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