Just a tiny refresher… are you approving suppliers and customers appropriately?
We posted about this topic before, as it is business and licence critical.
Suppliers and customers are on either side of you in the supply chain, and if you supply someone who is not appropriately licensed you are at risk of suspension, forced variation to remove the Responsible Person, or even revocation of your licence.
So what has changed since the last blog?
More criminals accessing licences, more people falling foul of regulatory inspections from the MHRA, lost money, risk to patients… all bad things!
What else can we do to reduce these risks? (Please remember you cannot eliminate risks completely! We still see Standard Operating Procedures talking about having “removed” the risk…
As you know by now, much of what we do is about quality and accuracy of records, documentation and evidence.
Building a good quality evidence base is useful on many levels… it shows you are attentive, gives a good amount to sample during audit, and will make the regulator happy.
Remember that one of the RP’s 12 duties is the quality and accuracy of records.
Audit new suppliers – It’s always a good thing to try and visit the company you buy from. Aside from seeing the bricks and mortar, you can get a far better idea of the reality of a supplier from visiting them. Review their temperature data, deviations, CAPAs, change controls etc.
Do they understand GDP? Are they compliant?
Need some audit training? Contact us.
Check your references – many people collect references, but don’t follow them up!
– Some say that the “Only good reference is a bad reference” but if you don’t at least check, document who you wrote/spoke to and date them, it doesn’t prove you followed up.
– Confirm separately, via LinkedIn or other sites, that the person you are calling is who they say they are.
– What is the job title of the person that is giving the reference? Sales person, accounts, other?
– Is the referee well known and reputable?
Collect evidence – Evidence of training, evidence of site visits… there are lots of different ways to achieve this now.
– We jokingly recommend taking a selfie at the site, with the client, however this is a perfectly good piece of evidence to show that you were there.
– Send yourself an email stating that you carried out some training with a member of staff, and print and file that later on.
– Take screenshots of websites you viewed, if you aren’t able to print the page and sign it. Try to have the date included in these.
Do proper Due Diligence – “I have their licence” is certainly no longer enough.
– Have you visited their premises?
– Checked on EUDRA?
– Asked colleagues, peers or competitors?
– Got a copy utility bill?
– Google map search?
– Google web search?
– Credit check?
– Companies House beta check?
– Confirmed the company bank details and money trail?
Be aware of “out of the ordinary” transactions – Is there something that doesn’t “feel” right?
– Are the quantities strange?
– Are people trying to access products that are suspicious?
– Are they trying to buy medicines of abuse, like Pregabalin and Gabapentin?
– Do they want to use a credit card, or money from a different bank account, or collect for export?
This list is NOT exhaustive… it’s some free and friendly advice.
Are your procedures up to speed?
Are you diligently checking all of your customers and suppliers?
Need a brush up?
Welcome to a new Paradigm!
2 Apr 2019
2 Apr 2019
12 Feb 2019
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