NOTE – the Draft PDF of the proposed changes (see the previous link) has changes highlighted in yellow. There are also two new clauses at the end (2.21 and 2.22) that are not highlighted for some reason but are new requirements.
The main proposed changes of this chapter are in line with the evolution of quality system thinking proposed in ICH 10. This will eventually become part of EU GMP formally via a new Annex 21 and an update to Chapter 1 on Quality Management. Comments on an update to Chapter 1 will come in a later blog.
Before the main proposed changes to this chapter are highlighted it is worth pointing out a few “issues” with the Chapter 2 Personnel.
Firstly, GMP provides details of three key personnel, namely the Head of Production, the Head of Quality Control and the Qualified Person in Chapter 2. Their main responsibilities are also described. There is absolutely no mention in EU GMP of a Quality Assurance (QA) Manager or even a QA Department. You do need a QA System, but there is no guidance at the moment on who is responsible for the QA System.
Secondly, there is no real mention of Top Management in GMP. Top Management are important for the successful leadership of an organisation, including its Quality System. You will see how the proposed update starts to address the role of Top Management, filling an existing gap.
The main proposed changes to the chapter are as follows:
Management responsible to resource the quality system (2.1)
Here you see the first mention of managers who are not Production or Quality Control, such as Human Resources (HR) and Finance. Whilst this is not enhanced you can see how there is at last recognition that at least HR and Finance departments can have a big impact on product quality and the whole quality system.
Senior Management and Leadership (2.3)
Here you see the importance of leadership and direction by top management. Without their buy in within organisations very little normally happens. Here we see an enhanced role for top management to formally take responsibility for the quality system and ensure that quality objectives, roles, responsibilities and authorities are defined throughout the organisation. Here we see again the idea that the quality system is not just confined to the GMP areas (Production and QC) – it should cover the whole organisation.
Quality Policy and Management Review (2.3)
Here we see the first mention in GMP of the requirement for a Quality Policy and Management Review (a forum where Top Management review their quality system). More detail of these will follow in a later blog on Chapter 1’s proposed updates, where Management Review is covered in more detail. For now Chapter 2 is just stating that Senior Management are responsible for ensuring that these are established and implemented.
Head of Production and Head of Quality Control are responsible for the effective implementation of the quality management system (2.7)
I think this is a disappointing part of this update, as every pharmaceutical organisation I have ever worked with has a Quality Assurance Manager who is responsible for operating the Quality System. Here is a golden opportunity to formally introduce the QA Manager into GMP, with roles and responsibilities defined, as they are for the Heads of Production, QC and the QP. I think this omission is a shame.
This is the first mention of consultants in EU GMP, yet they are already mentioned in USA GMP (21CFR211.34) and Active Pharmaceutical Ingredients GMP/ ICH Q7 (3.3). This new addition is almost the same as what is currently in USA GMP and API GMP.
Management of change in product ownership (2.22)
This covers some basic requirements associated with movement of products to and from a manufacturing site. The clause requires sites to ensure that all of the necessary information is provided and on-going responsibilities are defined. This is likely to cover, for example, post-release activities such as storage of retention samples, records, on-going stability studies, dealing with complaints, and so on.
These changes should not cause too many difficulties for organisations. Most, for example, already have Quality Policies and many are starting to do Management Review. The bigger change will come with updates to Chapter 1 and Annex 21 – and these will be covered in a later blog.
I hope that this article is of interest. Feel free to comment or pass on to others. For details of the full range of GMP and Quality Management courses we offer – please visit our website.
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
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