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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.

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Annex 1 has finally arrived, 25th Aug 2022 saw the publication of Annex 1. Normally, updates to GMP chapters and Annexes have a 6-month lead time for implementation. In the case of the new Annex 1, the lead time is 12 months, except for clause 8.123 relating to lyophilization which has 24 months lead time.

Annex 1 was first issued in 1971 as the only annex in the first ever UK guide to Good Manufacturing Practice. Since then, there have been several updates but not full revisions. In 2012 there was a proposal to revise Annex 1 with a re-proposal in 2014 by the UK’s MHRA. At the time, a full rewrite was considered unlikely and instead the intention was to provide a document that would confirm regulatory expectation and as such, not place any new requirements or costs on the pharmaceutical industry.

While this principle, is still upheld, it was clear from the first draft for public comment of December 2017, that a rewrite was being undertaken. The first draft created around 6200 comments coming from regulatory organizations, such as the pharmaceutical cooperation scheme, regulatory bodies outside of the EU, support organizations such as the Parenteral Drug Association, the Parenteral and Healthcare Sciences Society, the Pharmaceutical Microbiology Interest group as well as representatives from the manufacturers within the pharmaceutical industry to name just a few. Rarely do updates require a second public consultation but in the case of the annex 1 update a second draft was issued in March 2020 although this was a more targeted review in terms of the sections and clauses that comment was being sought for.

About the author

Andy Martin

Andy Martin

Andy started working in the Pharmaceutical industry in 1985 as a lab technician for Smith & Nephew.  Following this he had a number of roles culminating when he took over as QA Microbiology Manager.   In 2003 he moved into Pharmaceutical Training and then in 2007 he moved back into Microbiology when he took up the position of Microbiology Manager for Catalent Pharma Solutions.  Since 2012 he has operated as a consultant specialising in Microbiology and Quality Systems.

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