Dave Rushton
Founder
of Paradigm Shift Consulting Limited.
Dave Rushton is Founder of Paradigm Shift Consulting Limited, a Good Distribution Practice Consultancy.
Approval of Suppliers and Customers in GDP
Approval of Suppliers and Customers
Approving suppliers and customers is one of the key requirements of GDP, and with the 2013/C 343/01 update to the EU guidance it should now be standard for you and your team to gather more information on every company you work with. If you don’t perform checks correctly it could lead to falsified medicines entering the legal supply chain with serious consequences for you, including your licence being suspended/revoked, as it will mean you are being non-compliant.
Suppliers
Any organisation that you buy medicinal products from must have a wholesale distribution authorisation (WDA), or a manufacturing authorisation (MA) that covers the product(s) they are supplying.
A few different websites can be used to check the validity of a suppliers’ licences:
• The MHRA have a register of licensed distributor sites which is regularly updated, and can be used to search for the name of the supplier. It also gives the address and what they are licensed for. They also have a web page where you can see a list of manufacturers and wholesalers whose licences have been suspended or revoked ; companies to avoid working with. These are very handy tools for due diligence checks.
• The EudraGMDP website is also a good tool to use for finding out whether or not a listed country supplier or Northern Ireland supplier possesses the correct licences. It is essential that they are GDP compliant for you to purchase medicinal products/devices from them, otherwise you will also be non-compliant.
• The MHRA database of WDA and GDP Certificates is now live and supports searches for all UK sites.
Making Sure Of It
A printed copy or a screenshot of the web pages you have visited (complete with date and signature) can be used as evidence that you have performed the appropriate checks. These documents will need to be kept for your records and shown to an inspector during an MHRA inspection.
These details should be regularly checked, in case an incident occurs where the supplier’s WDA is suspended/revoked and they are no longer GDP compliant. If this is the case, you should no longer buy anything from them.
Due diligence checks should be made; the less well known the company the more checks may be required.
Where using larger wholesalers like Alliance Healthcare, Phoenix or AAH, they should still be checked; ensure that you qualify the depot that supplies your stock.
Customers
Anyone you sell to should have a “right to buy” either as another wholesaler, hospital, nurse, dentist, clinic, HCP (Healthcare professional), pharmacy etc.
For a full list of potential customers, check the MHRA Green Guide. Always look for the “MHRA Approved” logo on the websites. Be sure you can click on it and see the link to the appropiate register. This is very important in preventing misuse of supplies including medicines being sold illegally, which can put human health and life at risk.
Be Thorough
You should always check the licences of any wholesaler customers (as with suppliers), including their controlled drugs (CD) licence. This will also include checking if they have the correct entries on their licence to supply drugs, if that is their intent.
With every customer, make sure that all of their details are correct/real, to ensure that they are a legitimate customer. Even with hospitals and clinics, it may not be what it seems.
Check the amount that they are buying. Does it seem like an unusual/suspicious amount? Then think twice about whether that customer is legitimate and what their intentions could be with the products.
If you do have concerns, then report the matter to the MHRA to avoid a potential issue. It’s always better to be safe than sorry, especially when there could be a risk to human safety.
Looking into the reputation of suppliers and customers is also a very good idea. Ask your contacts if they have heard of or worked with the company and what they know about them. Are they reliable? Have they got a history of suspicious behaviour?
You should ensure that all relevant staff members, especially RPs, have training on bona fide checks for suppliers and customers, and that your procedures/documents are correct and up-to-date. If not, it could lead to dangerous substances entering the supply chain and posing a risk to human health.
Do you or your staff need training? To attend a training course on the EU GDP Guidelines such as our popular monthly webinar, visit our GDP Training Website (link button below) or telephone us for a no-obligation discussion. If required, we can arrange to come to your site to deliver training to a large groups, over a day or a few days, subject to Covid restrictions at the time.
If you need help approving suppliers and customers, we can arrange a free initial consultation to discuss how we can best help you. Use the contact form below at the foot of this page.