How to Qualify a Customer and Supplier for Wholesale Distribution
Verify both ends of every transaction before medicines move in either direction.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
Distribution is the point where falsified product enters the legitimate supply chain, and it enters through a trading partner nobody checked. Good distribution practice therefore requires verification in both directions: that a supplier is entitled to supply, and that a customer is entitled to receive. The check is not a credit check with a compliance label — it is confirmation of authorisation against the issuing register.
- 1
Verify the counterparty holds the authorisation it claims
Confirm the licence or authorisation against the register maintained by the issuing authority, not against a copy the counterparty sent you. A supplied certificate proves what somebody printed; the register proves what is currently in force.
- 2
Confirm the counterparty is entitled to the specific transaction
An authorisation has a scope. A wholesaler licensed for one category of product is not licensed for another, and a customer entitled to receive some products may not be entitled to receive controlled or restricted ones.
- 3
Assess the risk before you rely on paper alone
Unusually large orders, unusual product mixes, pressure to ship urgently, prices well away from the market, and new counterparties in unfamiliar jurisdictions all warrant deeper checks. The paperwork is easiest to falsify in exactly the transactions that most warrant suspicion.
- 4
Establish the relationship in a written agreement
Set out what each side is responsible for, how quality issues and recalls are communicated, and the conditions product will be handled under. An agreement is what makes an obligation enforceable when a recall requires action within hours.
- 5
Re-verify on a defined cycle and on any trigger
Authorisations expire, are varied, and are suspended. Verification performed once at onboarding certifies a state that has since changed, so re-verify periodically and immediately on any signal — a change of ownership, a regulatory action, a pattern shift in ordering.
- 6
Record the verification so it can be shown
Keep what was checked, against which register, on what date, and who checked it. A verification you performed and cannot evidence is indistinguishable from one you did not perform.
- !Authorisation accepted as a supplied copy rather than confirmed against the issuing register.
- !Scope unchecked, so a counterparty transacts in a product category its authorisation does not cover.
- !Qualification performed once at onboarding and never repeated as authorisations change.
- !Commercial red flags — urgency, unusual mix, off-market pricing — treated as sales opportunities.
How to Qualify a Customer and Supplier for Wholesale Distribution: frequently asked questions
Common questions on qualify a customer and supplier for wholesale distribution.
Why verify customers as well as suppliers?
Because diversion runs outward. Supplying a party not entitled to receive medicines puts product into a channel outside regulatory oversight, from which it can re-enter elsewhere. Verification in both directions is what keeps the chain closed, and it is a standing obligation rather than an onboarding step.
Is a copy of the licence enough?
No. A supplied document proves what someone produced; the register maintained by the issuing authority proves what is currently in force. Falsified authorisation documents exist precisely because copies are accepted, and checking the register costs minutes.
What should raise suspicion in an order?
Unusual quantities or product mixes, urgency that discourages checking, pricing well away from the market, a new counterparty in an unfamiliar jurisdiction, or a request to ship somewhere other than the authorised address. These are the conditions under which falsified product moves, and each is individually explicable — which is why the pattern matters more than any one signal.