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 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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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?
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.
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.
Actually Quality in the responsibility of everyone in the pharmaceutical supply chain. This needs to be supported by the CEO and senior management need to embrace the totality of Quality at every stage (from procurement of the raw materials to manufacturing and packaging and distribution) to ensure that the patient receives a safe and quality assured product.
The role of QA is not really to “harass” production. This is why some Indian Companies get into difficulty with EU and USA Regulatory Authorities during inspections. This mind-set has to change and QA recognised and accepted as defenders that safeguard the business and patient health.
Yogesh Krishan Davé
EU Qualified Person
Thanks Dominic for a very interesting article. Is it possible for the Site Director to also be the site QP?
Yes it is – this is normally the case in France for example.
Can the QP be hierarchically subordinated to the QC? and report functionally to other operation figures in the company ?
Yes – this is rare but correct. The QP can work anywhere in the organisation as long as they have sufficient oversight and authority and can legally discharge their duties correctly. They must be free from commercial pressure to release the batch.
If a company group exists of two or more legal entities, can one person fulfill the task of QP of two companies in the same group?
It may depend on what country you are in, but normally yes. You can have a Contract QP who may work for a number of organisations.
Where is it mentioned that the QP needs to be free from commercial pressure? For instance can the QP be also the Business Leader (knowing that QC is not part of his duties).
The location of a QP within a organisation can vary. This can also vary from country to country. In France, or example, the QP is often the site head, but often the QA sits within the QA Group. There is further guidance in EU GMP Annex 16.