We often hear negative comments about the MHRA, even during training sessions.
STOP IT!! It’s not only annoying, it’s incredibly ignorant and suggests you are a bit of a fool.
For those of us who are accountable and realise that we reap what we sow, we know that this advice is 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 meds and 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, and 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.
Their job 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 an RP from the licence.
There are a number of opportunities to resolve inspection deficiencies, even when reported to IAG, but all too sadly we are approached very last minute or after the suspension has hit.
We recently spoke to a company who were suspended for a number of issues, including selling sodium thiopental, and re-importing exported product.
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 isn’t.
Sadly, he doesn’t 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 (soon to go controlled) or to stupidly use prescriptions to secure pharmaceuticals and then wholesale them.
Why is this?
1) 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
2) Failing to ensure that an RP with appropriate competence and experience as well as knowledge of, and training in, GDP. EU Guidelines Chapter 2, Subsection 2.2
3) A lack of initial and continuing training relevant to the staff members role, based on written procedures and in accordance with a written training programme. The RP should maintain their competence in GDP through regular training. EU Guidelines Chapter 2, Subsection 2.4
4) A failure to attend the MHRA symposia.
5) A failure to recruit expert assistance to audit the site in advance of an MHRA inspection.
6) A failure to ensure that GDP is the spine of your quality management system.
7) Trying to bit off more than they can chew e.g. moving from a collection point model, to exporting worldwide.
8) 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, falsification, 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” – Hardly likely if you are behaving yourself, and 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 like an idiot, and put human health at risk, they may well get a sense of satisfaction shutting you down. They are only human, after all.
“They aren’t being fair.” – Bit childish? The regulator goes on facts and scientific evidence. If they are wrong, tell them why. Politely.
“Don’t tell the MHRA anything you don’t have to.” – Dumb, dumb, dumb. 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’s better to make the inspector aware and advise what you are doing to fix them, than to wait and “hope” they don’t find your issues.
Show your self-inspection, with your deviation reports and CAPAs.
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, vegetarian and 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, it’s not a good signal, unless it’s Ramadan. It may be that your refusal to be friendly and open has created a bad atmosphere, and this is a distraction.
You pay £1936 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, and look to implement every suggestion, documenting it in your response letter and a separate post-inspection report.
It may be 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, and 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 people, doing their job, to keep us and our families safe.
Help us spread the positive message, and shut down any foolish rhetoric from those who should know better.
It can seem “unfair” or harsh, sometimes, but it’s our responsibility to evidence compliance with the regulations, and not the Inspectors job to be our consultant or to tell us how to do our jobs.
On occasion the things we do to improve our standards can make a rod for our back… the easier it is to show we are compliant gives more time for other “digging.” For example a permanent temperature trace can evidence your summer and winter temps in seconds rather than minutes… but do you choose the weaker option to buy time?
Be honest, be open, never lie, and remember this is continual improvement… and try and get your value for money.
Every deficiency is a chance to grow, learn, and become stronger.
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Welcome to a new Paradigm!
20 Jun 2018
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