The MHRA are our friends… Even if it sometimes doesn’t feel like it.

The MHRA Are Here To Help 

Our team here at Paradigm Shift Consulting often hear negative comments about the MHRA, even during training our sessions.

“The MHRA should be chasing the real criminals.”

“I am being targeted by MHRA Inspectors.”

“The MHRA aren’t being fair.”

“Don’t tell the MHRA anything you don’t have to.”

“Don’t provide refreshments and they will leave sooner.”

“Wait until you get the MHRA post-inspection letter, there’s always less to do in the letter.”

“Don’t let the MHRA Inspector talk to your staff… give the day off to the bad ones.”

STOP IT!! The MHRA are not ‘out to get you!’
They have a job to do and that is to ensure manufacturers and distributors of medicinal products are not going to kill a patient by cutting corners, covering up mistakes, working in the ‘grey areas’ or who are flouting the rules and not taking accountability.
If you are not doing any of this, they have no reason to ‘target you’.  Stop being incredibly ignorant to the work of the MHRA and stop acting the fool; your ignorance will not help you during a regulatory inspection. And quite frankly, not providing refreshments is inhumane! 

For those of us in the industry who are accountable and do realise that we reap what we sow, we know that the ‘advice’ highlighted above, offered by some of the people we have met over the past 14 years whilst providing training and consultancy services, is utter nonsense.
For others it creates negativity towards the exact people who are here to protect us, and our loved ones, by doing their job… ensuring medicines and medical devices are safe. 

We’ll comment on each silly remark towards the end of this blog…

Let’s start with a few facts.

The Medicines and Healthcare products Regulatory Agency (MHRA) are the UK’s regulator of medicines, medical devices, and blood components for transfusion. They are responsible for ensuring their safety, quality and effectiveness.

The Inspectors from the Inspection Enforcement and Standards (IES) division are people, doing a very important job, which is to ensure that risks to human health are minimised and, where possible, removed.

In some cases that is by regulating sites, and escalating their deficiencies upwards to the Inspection Action Group (IAG) who may suspend or revoke licences, or force a variation to remove a Responsible Person (RP) from the licence.

There are a number of opportunities to resolve inspection deficiencies, even when reported to IAG, but sadly we are often approached for advice and access to our remediation services at the very last minute or after the license suspension has been applied.

We recently spoke to a company who were suspended for a number of issues, including selling sodium thiopental, and re-importing exported products.

They failed to realise that Switzerland is a third country: They failed to be aware of the Council regulation (EC) no 1236/2005 aka the EU Regulation on Products used for Capital Punishment and Torture.

They also were unaware of the amendment to these regulations on 20 Dec 2011, Council Regulation (EU) No 1352/2011 which includes short and intermediate acting barbituate anaesthestics.

The visiting inspectors told the Responsible Person he was not fit to be an RP and quite honestly, he wasn’t. Sadly, he did not seem to agree or recognise this fact.

This is not uncommon, just as it isn’t common for people to allow people to collect export orders, fail to collate CHIEF and C88 documents, to supply Pregabalin and Gabapentin (now a controlled medicine in the UK) or to stupidly use prescriptions to secure pharmaceuticals and then wholesale them.

Why is this?

• Management failing to ensure that all parts of the quality system are adequately resourced with competent personnel, and suitable and sufficient premises, equipment and facilities. EU Guidelines Chapter 1, Subsection 1.2
• Failing to ensure that an RP has appropriate competence and experience as well as knowledge of, and training in, GDP. EU Guidelines Chapter 2, Subsection 2.2
• A lack of initial and continuing training relevant to the licensable activities, staff members’ roles, based on written procedures and following a written training programme. The RP should maintain competence in GDP through regular training. EU Guidelines Chapter 2, Subsection 2.4
• A failure to attend the MHRA symposia.
• A failure to recruit expert assistance to audit the site before an MHRA inspection.
• A failure to ensure that GDP is the spine of your quality management system.
• Trying to bite off more than you can chew e.g. moving from a collection point model, to exporting worldwide.
• A failure of integrating a positive quality culture across the whole organisation, ensuring quality is not the sole responsibility of the quality department, all staff have a role to play.
• Thinking GDP is easy, and that collecting a few inhalers and ED tablets is “wholesaling.”

Nobody is perfect, and nobody knows everything… and it’s important to remain open to this and be continually learning and improving.

 Let’s revisit some of the bad advice that cycles around.

“The MHRA should be chasing the real criminals.”
They are! The MHRA Inspectors and Enforcement teams are involved in multiple cases, including illicit sales of controlled drugs, diversion of medicines, falsification of medicinal products and devices, sales of products from unlicensed sites, fake pharmacies and thefts… amongst other things.

Please also consider that if you are breaching the guidelines, regulations and legislation, YOU may also be a criminal.

“I am being targeted by MHRA Inspectors”
Very unlikely if you are mostly compliant and know what you are doing. If not, and you get regulated, they are just doing their job. If you behave in a way that puts human health at risk, they may well get a sense of satisfaction in shutting you down, and who can blame them.

“They aren’t being fair.”
The regulator goes on facts and scientific evidence and are very much led by the standards. If they are wrong, tell them why. Politely.

“Don’t tell the MHRA anything you don’t have to.”
Definitely not the way to do things. We will frequently raise our own open deficiencies in an inspection.

MHRA inspectors are trained auditors, and in some case have investigation or Police experience. Where you have issues, and are working to resolve them, it is far better to make the inspector aware and advise of what you are doing to fix them, than to wait and “hope” they don’t find your issues.

1. Show your self-inspection findings, with your associated deviation reports and CAPAs.
2. Evidence contemporaneous change controls, and user requirement specifications.

“Don’t provide refreshments and they will leave sooner.”
Aside from being somewhat rude, a lack of refreshments will not stop an inspector in their duty.

We recommend bringing a selection of foods, meat and vegetarian, then at around lunchtime suggest a brief, working lunch. Be prepared! Don’t ask “do you want a meal?”; just provide the option and break for ten or fifteen minutes to eat, before continuing.

If the Inspector refuses, this is not usually a good signal, unless it’s Ramadan. It may be that your refusal to be friendly and open has created a bad or hostile atmosphere, and this is a distraction.

“Wait until you get the MHRA post-inspection letter, there’s always less to do in the letter.” 
Correct, but again a bit daft.
You pay £2662 + VAT for an inspection. Every piece of good advice that the Inspector offers you has a “pound value.” Take copious notes, listen, be compliant, admit when you don’t have the document they are requesting, and look to implement every suggestion, documenting it in your response letter as well as a separate post-inspection report.

It may be that the next Inspector disagrees with the action, and we recommend you don’t argue about it, explain what was advised before, and show your report, then suggest a better match for what this inspector wants.

Note: There are occasionally differences between Inspectors. Some Inspectors have a particular focus like temperature control, bona fides, risk management or data integrity, but the Inspectorate meet regularly to be as consistent as possible. Accept it, don’t argue, grow, learn.

“Don’t let the MHRA Inspector talk to your staff… give the day off to the bad ones.”
If you have staff that you aren’t comfortable with speaking to the Inspector it means they shouldn’t be working in the wholesale business.
Shyness is fine. Lack of knowledge, and skill, is not. If they aren’t skilled or knowledgeable, should they be working there? Invest in your people, they are handling human medicines, and your money. If any staff aren’t fit to be interviewed, give them training, support and an understanding of the requirements of GDP and quality.

So… the MHRA may not seem like our ‘friends’ when they are regulating us, but they are just doing their job to keep us and our families safe.

Help us spread the positive message, and shut down any negatives from those who should know better.

It can seem “unfair” or harsh at times, but it’s our responsibility to evidence compliance with the regulations and not the Inspector’s job to be our consultant or to tell us how to do our jobs.

Be honest, be open, never lie, and remember this is continual improvement. Try and get your value for money. Every deficiency is a chance to grow, learn, and become stronger.

Need a pre-inspection audit?
Did you have an inspection that didn’t go as well as you had hoped? 
Have you been referred to CMT or IAG? 
Paradigm Shift can help, providing you want to be helped and are prepared to put in the work!

Are you worried that the world of GDP is passing you by?
Join us for  GDP training. We offer a wide range of courses from full and comprehensive webinars for RP’s and Licence Holders, to GDP awareness training for all staff, to activity specific courses e.g. Deviation Management, Change Control Implementation and Warehouse Operations. 
Find out more at GDPTraining.co.uk 

Do you need a free five-minute consultation? 

Contact us for more information on how we can help or take a look at our Compliance Support Memberships and how they could benefit you!

Welcome to a new Paradigm!