A new update to EU GMP Chapter 2 has been issued and comes into operation on 16th February 2014. Here is a summary of the main changes from the previous version Chapter 2 Personnel OLD. A copy of the new version can be found by clicking on the link Chapter 2 Personnel NEW.
There is a greater role and coverage for the first time of Senior Management in the new chapter. This is in line with requirements from ICH Q10 on the Pharmaceutical Quality System. These includes:
To determine and provide appropriate resources (which could be human (people), financial, materials, facilities and equipment) [clause 2.1]. This should not only be sufficient to maintain the status-quo as there should also be sufficient resources to facilitate continual improvement. Here we see “continual improvement” added to another new chapter of GMP. It was first introduced in the update to Chapter 1 earlier this year Chapter 1 Pharma Quality System. This introduction of “continual improvement” follows the shift of emphasis of the GMP quality system as it expands from more than just a focus on product conformity.
Senior Management are also ultimately responsible for the whole Quality Management System [clause 2.4]. This is in line with ISO 9001 requirements and is generally what should happen in all leading industries. The quality system is Top Management’s system and should be linked with the needs of the whole business. To that end, and in the same clause, Senior Management are responsible for establishing a Quality Policy and Quality Objectives and that roles and responsibilities are defined and understood throughout the organisation. Here again principles of ISO 9001 and ICHQ10 arrive in a main GMP chapter. Again (as in the new Chapter 1) we also see expansion of the coverage of the Quality System – not just for Production areas but “throughout the organisation”.
Finally, in the same clause, Senior Management must also partake in Management Review meetings – a fora designed to review the whole Quality Management System.
The Head of Quality:
In the section on Key Personnel there is an arrival (and you may be surprised to realise this) that for the first time the Head of Quality Assurance gets a mention. Historically GMP has always been out of touch with what really happens at a manufacturing site, with up until now only roles defined in GMP for the Head of Production, Head of Quality Control and the Qualified Person (QP). Now, at last, this “QA gap” appears to start to be filled, as the enhanced role for the Head of Quality Control can also be performed by a Head of Quality Assurance or even a Head of Quality. This is closer to normal practice at most manufacturing sites – where you generally find a Head of Quality and reporting to them is a Head of QA and a Head of QC.
The Qualified Person:
There are some changes for the responsibilities of a Qualified Person [clause 2.6]. These changes are more detail related rather than perhaps having to do anything differently. The main change [clause 2.6b] is more detailed on the need for full qualitative analysis and/or testing of imported materials. In the previous version this testing needed to be performed in the importing country – but now it can occur in any country. Useful, perhaps, if an EU member state has no laboratories available to do a specific test.
The Head of Quality Control / Head of Quality:
There are also a few more requirements stated for the Head of Quality Control [clause 2.9], which could be performed by the Head of Quality Assurance or even the Head of Quality. These include additional responsibility of any outsourced activity [2.9vii]. This follows the recent (January 2013) update of Chapter 7 on Outsourced Activities, which previously just covered outsourced manufacturing and/or testing Chapter 7 Outsourced activities.
There is also a requirement for the Head of Quality to participate in Management Review meetings [2.9xii] and being promoters of continual improvement. So QA people reading this – as I have said for many years, your job has changed. You are not just looking for compliance – but how improvements can be made too. Improvements to product quality, process performance and the whole system.
There is also the need for suitable systems in place to ensure timely and effective communication and escalation of quality related issues to management.
Finally in the chapter there is a new clause [2.23] on consultants. This is taken from USA GMP. If you use consultants (and most firms do) then you need a record of their training, education and experience.
Training in the evolved role of Quality Assurance:
The chapter certainly touches on an evolved role for Quality Assurance. SElect the links on this page to find out more about on-line and classroom based courses that we offer for QA personnel and trainee QPs.
I hope this is useful. Dominic
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 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
Find out about our course ranges