Are you preparing for an MHRA remote inspection? COVID-19 threw a spanner in the works for almost all dimensions of modern business.
Site closures, remote working and a digital shift have taken hold almost everywhere – and the MHRA’s audit and inspection programme is no different.
Now, rather than welcoming an inspector through your door, they’ll appear in a window on your computer screen. Instead of leading them around your lab or document storage area, you’ll be guiding them through electronic files and passing digital folders over to them.
Struggling to keep up? Here’s what you should know about the MHRA’s remote inspection initiative:
In March 2020, as the COVID-19 pandemic took full effect, the MHRA announced the suspension of all non-essential, non-COVID-related GxP on-site inspections.
If your business is directly involved in clinical trial, manufacturing, distribution, pharmacovigilance or lab work connected to COVID-19 or another major public health initiative, then the shift to remote won’t have affected you at all.
Inspectors can still physically visit you – and can even perform unannounced inspections as before.
But for everyone else…
What is a remote MHRA inspection? And how do you prepare for one?
There’s no denying that audits and inspections are stressful at the best of times. Adapting on the fly to a new inspection tactic in the midst of a pandemic does not make things easier.
Preparing for your remote MHRA inspection
The best way to prepare for any inspection or audit is not to have to prepare at all.
That is – a constant, familiar state of MHRA inspection readiness should be built wherever possible. Robust, repeatable processes, easily accessible information and engagement from senior management are all key steps on this journey, as is keeping on top of crucial day-to-day tasks like your trial master file upkeep.
But even the best-prepared business will have to make some changes to adapt to the world of remote inspections.
Chief among these are:
1. Electronic documentation
Digitisation was a recommended way of strengthening, speeding up and centralising your information streams before COVID-19. Now it’s unavoidable. If you’re already using an electronic document management system, great! You’re already prepared.
If not, get to work scanning your SOPs, records, reports – anything you think will be relevant for your inspection. You’ll get an initial request a few days before your inspection begins for you to start pulling together key information for dispatch via email.
Make sure you react quickly to this initial request and go one further by preparing additional or supplementary documents you think will be relevant. Even if your inspector doesn’t actively request them on Day 1, having them to hand for quick referral or to respond to additional requests will make the whole process easier.
Having designated staff on hand to answer technical questions or retrieve requested information has always been a good way to impress your inspector and keep the inspection process smooth and painless. You’ll still need to consider how you’ll do this during a remote inspection.
Email threads and online conversation groups are a good way to keep everyone aligned before and during the inspection. Ensure key personnel are informed and ready to join a teleconference at a moment’s notice. Above all, the speed of your response to your inspector’s requests and queries will be a key indicator of the strength of your quality system and your GxP processes – so consider a dummy run with your teammates before the inspection begins to make it clear who will be called on to support which areas of the inspection.
3. Platforms and format
No – you won’t be in an all-day virtual meeting with your inspector, answering the odd question as they leaf through your document stack.
Remote MHRA inspections typically follow an ‘info request then follow-up’ format, with your inspector going away to digest and analyse the documentation you send over before joining a teleconference with you to ask questions, dig deeper and request additional information.
A teleconference platform like Zoom, Skype or Teams will be needed for these collaborative sessions, with email used to transmit requested documents. Sharing screens is a good way to work through key documents with your inspector and prevent excessive back-and-forth email chains. As in a regular inspection, be candid, approachable and truthful in your responses.
You can expect an opening and closing session in your inspection, with a number of ad hoc follow-up sessions in the middle.
4. Multi-phase inspections
Due to the nature of remote inspections, it’s unlikely your inspector will cover all the areas they would in a full physical face-to-face session.
Surveying your clinical trial facilities, inspecting study data or touring your manufacturing line are all obviously impossible virtually – so it’s likely your inspection will focus on a general topline observation of the systems and processes in place for your GxP operation.
With that in mind, a multi-phase inspection is likely, with the physical portion of your inspection earmarked for a future date. Prepare accordingly.
The return to normal (?)
With the gradual easing of lockdown restrictions, the MHRA announced in August its intention to return to on-site inspections in September, scaling up to a full physical inspection programme by October.
But this doesn’t mean that remote inspection practices will be retired altogether. Rather a ‘mixed’ inspection format will emerge, combining on-site surveillance with continued remote and digitised operations.
When an on-site inspection is announced, you’ll be given 14 days’ notice to get your COVID-19 risk mitigation procedures in place and discuss them with your inspector to ensure you’re aligned.
As with a remote inspection, digital documentation will be requested in advance and should be used as much as possible throughout the inspection.
You won’t need to:
• Prepare any paper documents especially for the inspection
• Bring personnel on-site solely for the inspection
• Prepare an inspection backroom
But you should assign at least one member of staff to escort and converse with the inspector, with additional staff and subject matter experts standing by digitally (as they would for a remote inspection) where necessary.
Face-to-face contact will be minimised, with the minimum number of people attending in-person interviews with the inspector. To this end, video conferencing may be used even if you’re on-site.
With that in mind, the practices you put in place for your remote MHRA inspections – electronic documentation, screen-sharing, designated personnel – will remain relevant for the foreseeable, even as some on-site inspection elements are slowly reintroduced.