In the MHRA Annual Report 2024 that has recently been published there is a summary of the inspections carried out by the various GxP teams on page 46.
The figures for both GMP and GDP Inspections show that the numbers of completed inspections in 2023/24 has reduced from previous years. The number of inspections completed by the GDP team of 387 inspections in 2023/24 is the fewest carried out since the creation of the team. (Excepting 2020 Covid year). Of the 387 inspections that would count both physical and remote inspections (possibly including RP assessments).
To put those numbers in context the team when at full complement in the period 2012- 2019 was carrying out around 1000 inspections a year. There were around 2200 WDA(H)s up until Brexit and the number is now 1840.
What does it mean for MHRA?
That the Risk based inspection programme for GDP can be barely scratching the surface of the number of inspections that should be completed. The highest risk categories use to be, re-inspecting new applications within 9 months, intelligence led inspections, revisits to poor compliant companies at IAG or CMT, companies not inspected in the last 5 years.
There looks to be around 120 new wholesale dealer licences from July 2023 to Jun 2024. Just the remote inspection of these applications and with a plan to re-inspect these within 9 months of approval will have taken a lot of the inspection resource.
There is a significant gap in covering the number of inspections that are expected of the 1840 WDA(H)s to cover the higher risk companies or get close to a 4 year inspection cycle of licence based inspections.
I have talked to companies with full WDA(H)s that haven’t been inspected since 2015 / 2016. It is hard to assess the compliance of companies if they are inspected so infrequently. Many GDP certificates are over 5 years old and its is hard to see what use these are anymore.
Countries from Argentina to Zanzibar have implemented serialisation to protect their medicines supply chains. The UK is increasingly isolated as a country with no equivalent system to ensure the authenticity of medicines. This is not necessary an issue if there is a strong and active inspection programme to police the supply chain. Based on these figures that is not the case in the UK. Even when 1000 inspections were being conducted annually, many cases of illegal activities were being uncovered by inspectors and IAG was kept busy – with less inspections I’m genuinely concerned about what may be slipping under the radar.
Why are there fewer inspections?
Quite simply – far small number of inspectors.
You can see comparative organograms for 2024 and 2021 for GMP and GDP on my blog.
Why are there fewer inspectors?
For several reasons, but in my opinion, pay is a significant reason, along with the length of time it takes to recruit and train new inspectors. It can easily take 18 to 24 months to recruit then train an inspector to become accredited.
Hopefully, this is a short-term blip and there is active recruitment and training in place…
What does it mean for distributors, MAHs and patients?
As the pharma industry we should be concerned, although no one enjoys an inspection I strongly believe that a well-regulated industry overseen by knowledgeable Regulators is a fundamental part of ensuring patients get the best quality medication.
As we have all seen from banking to water, weak and ineffective regulation in the long term has caused nothing but problems for all of us.
Of course, Licence Holders are legally required to ensure compliance with GDP and the Human Medicines Regulations, but if companies do not get inspected standards inevitably start to drop.
Companies need to ensure on-going compliance with GDP even if infrequently inspected. Time spent considering risk assessments on suppliers and customers and potential audits, where no recent MHRA inspection has been completed, will likely become an important part of supply chain management.
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