GMP Management Review meetings
The idea of Management Review meetings has only been a formal GMP requirement for the past 5 years or so. In the many visits that I do to pharmaceutical manufacturing sites I see these done – but rarely done well, which is a real shame. So what are these GMP Management Review meetings, why do we have them, what should be discussed, who should attend and how often should we have them?
What are these meetings?
They are an idea taken from ISO 9001 that were formally part of GMP in Europe since the new updates to EU GMP Chapters 1 and 2 from January 2013 and February 2014 respectively. Not that these chapters say very much about GMP Management Review. Chapter 1 states: “There should be periodic management review, with the involvement of senior management, of the operation of the Pharmaceutical Quality System to identify opportunities for continual improvement of products, processes and the system itself” (clause 1.6). Chapter 2 states that the Heads of Product and Quality Control should “participate in management reviews of process performance, product quality and of the quality management system and advocating continual improvement” (clause 2.9) and that “Senior management … should ensure continuing suitability and effectiveness of the Quality Management System and GMP compliance through participation in Management Review” (clause 2.4). So here we see the need for these meetings, but nothing said on what they are really about.
Why do we have them?
The quotes above give us a good indication of why we have them, so that Senior Management can assess how the whole Quality Management System (QMS) is performing.
What should be discussed?
This is where the quotes from GMP above are of limited help, as they do not tell us what should be discussed. But, we don’t give up – we can look elsewhere. That “elsewhere” is ICH Q10. This gives us much more guidance. At various locations in ICH Q10 (and it is a shame that it is many places rather than one) is states that GMP Management Review should discuss:
ICH Q10 Clause 3.2.4:
The management review system should include:
(1) The results of regulatory inspections and findings, audits and other assessments, and commitments made to regulatory authorities
(2) Periodic quality reviews, that can include:
(i) Measures of customer satisfaction such as product quality complaints and recalls
(ii) Conclusions of process performance and product quality monitoring
(iii) The effectiveness of process and product changes including those arising from corrective action and preventive actions
(3) Any follow-up actions from previous management reviews
The management review system should identify appropriate actions, such as:
(1) Improvements to manufacturing processes and products
(2) Provision, training and/or realignment of resources
(3) Capture and dissemination of knowledge
ICH Q10 Clause 4.1:
Management should have a formal process for reviewing the pharmaceutical quality system on a periodic basis. The review should include:
(a) Measurement of achievement of pharmaceutical quality system objectives
(b) Assessment of performance indicators that can be used to monitor the effectiveness of processes within the pharmaceutical quality system, such as:
(1) Complaint, deviation, CAPA and change management processes
(2) Feedback on outsourced activities
(3) Self-assessment processes including risk assessments, trending, and audits
(4) External assessments such as regulatory inspections and findings and customer audits
ICH Q10 Clause 4.2:
Factors monitored by management can include:
(a) Emerging regulations, guidance and quality issues that can impact the Pharmaceutical Quality System
(b) Innovations that might enhance the pharmaceutical quality system
(c) Changes in business environment and objectives
(d) Changes in product ownership
Plus there should be outputs from Management Review.
ICH Q10 Clause 4.3:
The outcome of management review of the pharmaceutical quality system and monitoring of internal and external factors can include:
(a) Improvements to the pharmaceutical quality system and related processes
(b) Allocation or reallocation of resources and/or personnel training
(c) Revisions to quality policy and quality objectives
(d) Documentation and timely and effective communication of the results of the management review and actions, including escalation of appropriate issues to senior management
This is a very detailed list. In fact I have never seen such a clear and detailed list of what should be discussed at these GMP Management Review Meetings in any standard. We can also see here a mix of reviewing the past (such as conclusions of process performance and product quality monitoring), what has gone wrong (such as product quality complaints and recalls) and the future too (such as emerging regulations, innovations and changes). It is here where I see these meetings not being made the most of – with too much time discussing problems and not enough time looking towards the future.
Who should attend?
All of the Senior Management team. It is clear from the earlier quote from clause 2.4. They run the business and this is the forum to review the business and the system. Also note that ICH Q10 also states (clause 3.2.4) that “depending on the size and complexity of the company, management review can be a series of reviews at various levels of management and should include a timely and effective communication and escalation process to raise appropriate quality issues to senior levels of management for review”. In other words, there can be a series of mini-reviews, held at various times and perhaps locations that can discuss all of the above. Good discussions can take place at Daily Production or Line meetings, weekly meetings, departmental briefings. These are all mechanisms that can be used to make Management Review something that works throughout the organisation.
How often should we have them?
This is not clear and not stated in GMP – but I fail to be impressed by any organisation that holds them annually. This is just too long a gap (if there is only a single meeting) and I prefer to see these meetings monthly or at least quarterly. As the agenda topic from above is lengthy, then there is no reason why focus meetings cannot take place, looking at core topics at all meetings (such as deviation, complaints and problems), and additional topics at selected meetings (such as customer satisfaction, quality policy revision and dissemination of knowledge). This way all of the issues can be covered at various points throughout the year.
I do believe that Management Review is an essential part of your QMS, and if used correctly can be a real force for good, rather than a regulatory necessity.
I hope that this article is of interest and it would be great if you would add your comments on your experiences in this important area of GMP and QMS.
If you are interested to learn more about GMP Management Review and how to run a compliant Pharmaceutical Quality Management Systems, then consider attending one of our Quality Management Systems training courses.
This article should be read in conjunction with an earlier article on GMP Management Review.
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.
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