
Qualify suppliers before purchase
Manufacturers, importers and wholesalers are checked against product, activity, location and supply route.
- Verify identity and legal entity
- Check manufacturing or wholesale authorisation
- Match site and authorised scope
- Document approval before first receipt

Verify customers and delivery addresses
Recipient eligibility must match the product, activity and actual delivery point.
- Classify pharmacy, wholesaler or other recipient
- Verify licence and registered site
- Control alternative delivery addresses
- Reassess changes before delivery

Licences, certificates and registers
Register results are interpreted for scope, status, site and date; one document alone is not sufficient.
- Use EudraGMDP and national registers
- Monitor expiry and status changes
- Identify diversion or falsification signals
- Retain review evidence

Risk, audit and ongoing monitoring
Criticality and performance determine audit frequency, agreements and review cycles.
- Risk class and requalification cycle
- Quality or technical agreement
- KPI, complaint and deviation monitoring
- Blocking and escalation workflow

Assign GDP findings to the Responsible Person and the operating team
Audit findings and partner decisions need a defined owner and escalation route. Review which actions sit with operations, management or the Responsible Person. Where external Responsible Person support is being considered for German wholesale, agree duties, access to records and availability before the mandate starts.
Define suitability, responsibilities, cooperation and coverage. External Responsible Person for German pharmaceutical wholesale →