MHRA INSPECTIONS
Considerations for before, during and after
an inspection
In this series of articles, I walk you through both the processes as well as the preparation surrounding MHRA inspections. I will help you understand the best way to approach an MHRA inspection – to get the most out of it, to demonstrate what you do well and, most of all, to demonstrate a commitment to public safety. And we’ll look at best practices long before a letter from the MHRA arrives.
Part 1 – So the MHRA letter arrives
5 critical steps to what happens next
1 – You are where you are.
Typically, an MHRA inspection notification will give you between two to four weeks advance notice. It’s unlikely that anything you do at this stage will fundamentally change your systems and processes to an extent that would impact on an inspection outcome. Re-shaping everything you already do to impress the inspector will probably undermine what you are doing well, however, it’s certainly worth checking to make sure, what you think should be happening, is actually taking place.
2 – Do you need to change anything?
Checking can assess if all your systems and processes are working? Knowledge of your systems and processes is a great base for improvement or fine tuning. An honest appraisal of your system is vital before an inspector points out issues.
3 – Proactive rather than reactive.
If you do find areas that need fine tuning, you’re better off concentrating on the recording of observed areas that need improvement rather than applying sticking plaster solutions. Letting the inspector know you’ve identified such areas will fill them with greater confidence than uncovering any fixes that are half-baked.
4 – Take encouragement from what you see is going right.
Don’t forget, where systems and processes work well it will indicate a level of competence that can be deployed in other areas you may find are currently problematic.
5 – Let your staff know there is going to be an inspection, make them feel part of it.
Staff need to be encouraged to feel confident to answer honestly if they are asked questions by an inspector. They know the job better than anyone so allowing them the opportunity to show their expertise is crucial.
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Early preparation is key; taking time to consider what may be required well before the MHRA letter drops through your door will lessen the impact, and make the inspection a more relaxed experience and the SeerPharma UK team are here to help you.
Look out for my next article where I will guide you through how to prepare for an inspection including;
Gamekeeper turned poacher?
Many of you will know me as an MHRA Senior GDP inspector. I joined the MHRA back in 2009 and have spoken to hundreds, probably thousands, of industry professionals over the years – from CEOs and CFOs, RPs and License Holders, to warehouse staff and admin workers. The role gives inspectors a broad, deep and I would say unique view of the industry.
I left the MHRA in January 2022 to join SeerPharma UK as a consultant. Some might see this new role as ‘gamekeeper’ turned ‘poacher’ but of course we are no less committed to public safety now than before. What is different is I and my colleagues can now advise businesses on how to meet regulatory requirements in ways that are the most efficient and achievable rather than just highlighting areas for compliance that an inspector is limited to. This allows us to help businesses remain both profitable and compliant whist fulfilling their critical public health role.
Gaynor Brummit
Director and Senior Consultant, SeerPharma UK
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