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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.

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