For course details click on the subject areas shown in menu below. To contact us: +44 1635 866699

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 first principle associated with such implementation – that of adequately assigning roles and responsibilities.

The establishment and operation of an effective Quality Management System requires, in the first instance, appropriate design and development. Having designed our Quality Management System we should now consider the effective implementation of that system.

We need confidence and assurance in the effective operation of our system – this confidence and assurance will be gained through the systems we put in place and, most importantly, through the people that operate within these systems. Hence the absolute need to define the roles and responsibilities individuals have within these systems.

In the UK’s Orange Guide (containing EU GMP) of 2002 it was stated that “the great majority of reported defective medicinal products has resulted from human error or carelessness, not from failures in technology”. Not the fault of technology but the fault of the individual. Our fault! But perhaps such individual failing is more the result of a failure to adequately set down roles and responsibilities.

Whilst the system performance ultimately depends on the people operating within it relatively little is said, in general terms, about the need to define their roles and responsibilities. See video below to understand why this is critical:

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

Related Articles

Find out about our course ranges

GMP Training


QMS Training


GDP/RP Training


GMP Compliance


QP Training


GDP Compliance


Free Taster courses

To try a free taster of our online courses to see if they are of interest visit this page.