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 and 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. Review their temperature data, deviations, CAPAs, change controls etc… do they understand GDP?
Need some audit training? Contact us.
Check your references – many people collect references, but don’t follow them up!
Collect evidence – Evidence of training, evidence of site visits… lots of different ways to achieve this now.
Do proper Due Diligence – “I have their licence” is certainly no longer enough.
Be aware of “out of the ordinary” transactions – Is there something that doesn’t “feel” right?
This is NOT exhaustive… it’s some free and friendly advice.
Are your procedures up to speed?
Are you diligently checking customers and suppliers?
Need a brush up?
Welcome to a new Paradigm!
17 Oct 2018
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