With fresh updates from the MHRA - Here is a breakdown and overview of what it all means.
GMP & GDP Certificates: Validity Period Extended
Following the end of COVID-19 in May 2023, on-site GMP and GDP inspections were resumed. (1,2)
The GMP and GDP certificates' previous extension of validity has been maintained by the MHRA until 2024, or until the end of the next inspection, whichever is the nearest date (3).
The MHRA maintains the authority to conduct risk-based supervision of sites through on-site or remote inspections, which allows them to withdraw or restrict GDP and GMP certificates.
'' The "expiry" date of international GMP certificates has been extended to the end of 2023 following a successful pilot study that began in April 2022 to assess the possibility of reinstating international onsite GMP inspections. Using a risk-based approach, the MHRA will give priority to inspections that have the biggest effects on patient safety and public health in the UK (4). ''
However, in the UK, in a much more recent update, inspections will continue to be prioritised based on risk so that the highest priority manufacturers and wholesale distributors are inspected first.
In this system of priorities, GMP or GDP certificates that are five years old or more are going to be given precedence.
''Inspections may be carried out at any time, and in case of serious non-compliance, appropriate regulatory actions will be taken (5). ''
What impact does this have on you?
Your Staff Training
Training or maybe even a company wide email may be needed so that staff are aware of the new extension of the validity of GMP/ GDP certificates, specifically Purchasing, Sales and of course members of staff that deal directly with Bona Fides.
Company Relations
Some small amount of friction may be seen between companies in communication concerning GDP & GMP certificates. Mostly due to the lack of certificates that have occurred during covid and the abundance of "expired" certificates. For example, the company may have moved operations to a new site they still lack the GMP/GDP certificate for. This would be because the MHRA wouldn't have inspected the site as its reformed its inspection plan to focus more of Licence base inspections rather than site focused.
This issue may even go as far as restricting certain areas of trade as some companies require this documentation before trading, whether that be restricting the amount bought/made/sole or even the seize of any business with the other company
Giving Trust
The MHRA are giving a lot of trust to companies that they are keeping up with guidelines.
This may not be a huge problem for larger companies that have variation or history to show that they are keeping to guidelines and showing business etiquette. However, newer or smaller companies may not have this to fall back on. New applications are not slowing down by any means and this may further push back on inspections, can newer companies afford not to have GMP & GDP Certificates?
Integrity
A backlog of several extensions may cause the documentation's integrity to become somewhat compromised. Covid 19 has not aided in any way with the approval of documentation timeframe, and in this instance, some wiggle room is appropriate.
How can this be overcome?
Maintaining patient safety while adhering to license requirements can be difficult, so here is what can modus do for you...
Our team specialises in giving you the know-how and resources required to guarantee adherence to regulations and industry standards. Keeping updated on new MHRA rules and regulations in this ever-changing environment.
Due to this changing environment we understand it can be challenging to decipher regulations, so we've done it for you.
Knowledge is essential for changing a company's culture. All of this requires time, which is very valuable. Make use of your personnel and delegate the labour-intensive tasks to us so that you can concentrate on growing, developing, and making the important decisions.
How this can lead to further changes or new regulations
This new extension could have a effect on new regulations, process and may even extend to patient to some extent, the MHRA is placing a great deal of reliance on Companies, RPs, and personnel to continue adhering to the guidelines that have been set.
This new extension may have an positive impact on new regulations, with technology advancing swiftly, they might rely even more on remote inspection in the future to support the MHRA in this endeavour. Due to new potential regulations surrounding licencing, this would shorten the backlog of people awaiting WDAs, CD licences, and certifications (GDP & GMP). This would enable more consistent trade within the business.
While some of these impacts might improve things, we must be mindful that these extensions and advancements to possible processes might have negative effects in addition to any advancements they might represent. If businesses are not as strictly regulated as they are currently, they can start to take shortcuts or have mistakes that go unnoticed, endangering patient safety.
Sources
1 - World Health Organisation (2023) 'Statement on the fifteenth meeting of the IHR (2005) Emergency Committee on the COVID-19 pandemic'. Available at: Statement on the fifteenth meeting of the IHR (2005) Emergency Committee on the COVID-19 pandemic (who.int).
2 - U.S Department of Health and Human Services (2023) 'End of the COVID-19 Public Health Emergency', HHS Press Office. Available at: Fact Sheet: End of the COVID-19 Public Health Emergency | HHS.gov
3 - European Medicines Agency (2023) 'Good manufacturing practice',
European Union agencies network. Available at: Good manufacturing practice | European Medicines Agency (europa.eu)
4 - Carrol, G., (2022) 'Return to International GMP Inspections', Medicines and Healthcare Products Regulatory Agency. Available at: Return to International GMP Inspections - MHRA Inspectorate (blog.gov.uk)
5 - MHRA (2023) 'Notes for applicants and holders of a Wholesale Dealer’s Licence (WDA(H) … Inspections', Medicines and Healthcare Products Regulatory Agency. Available at: Notes for applicants and holders of a Wholesale Dealer’s Licence (WDA(H)) or Broker Registration - GOV.UK (www.gov.uk)
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