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The video in this article is part of a unit in our online QMS courses (see below) that looks at how to implement a Quality Management System and, in this video, we look at “The roles of the Heads of Production & QC and the Qualified Person” and what GMP’s requirements are when it comes to roles and responsibilities as well as the specific duties of these three individuals.

The main chapter of EU GMP that covers people is Chapter 2 on “Personnel”.  Within Chapter 2 (clause 2.2) it states that an organisation must have an organisation chart, people must have job descriptions and there must be no gaps or overlaps in the responsibilities for GMP.  It also states at clause 2.1 that an organisation must have an adequate number of suitably trained and experienced personnel and no individual should be excessively overloaded with responsibilities that they can have a negative impact on product quality.  This final statement seems to become more of a challenge every year – especially when staff are asked to do more work with less resources!  It is still though a valid and important requirement of GMP.

The three people named on a manufacturing site’s Manufacturing Licence (or Manufacturing Authorisation) are the Head of Production, the Head of Quality Control and the Qualified Person (QP) or QPs (as you may have more than one Qualified Person).  GMP (and the Regulatory Authorities) prefer these people to be in full-time positions.  The Head of Production and the Head of Quality Control (QC) cannot be the same person as Article 11 of the GMP Directive (2003/94/EC or the equivalent Veterinary Directive) makes it a legal requirement that QC is independent of Production.

Within GMP the duties of all of these individuals are described.  In small organisations it may well be that these people actually do all of these tasks themselves, but in larger organisations then inevitably an increasing amount of delegation will occur.  This is permitted by GMP (clause 2.2) as long as the delegation is to suitably competent and qualified individuals.  However, even if this delegation does take place these three individuals are always ultimately responsible for ensuring that their GMP requirements are performed satisfactorily.

In the video below the 3 roles are explored in more detail:

This video is taken from Unit 3 of our Pharma QMS online course and our QP QMS course.

Also visit this article about the role of key GMP personnel.

You can see more viseos from our QMS online courses by visiting our Vimeo site.

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.

Training courses on Annex 1

There are a number of half-day workshops organised to take you through the changes in more detail and to look at how they relate to your organisation.

Our 2-day course is updated for Annex 1 changes

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