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Wholesalers distribute medicinal products and are licenced in Good Distribution Practice (GDP)
There is a long-established system in place to distribute medicinal products throughout the UK. Wholesalers purchase the products from pharma companies. The wholesalers then take over with a remit to supply hospital and community pharmacies, clinics, GP surgeries, and sometimes, the patient’s home.
Wholesalers need a licence called a Wholesale Distribution Authorisation (aka Wholesale Dealer Licence) to be able to operate. To get the licence, they need to be inspected to prove they are compliant with Good Distribution Practice (GDP).
These are the areas inspected:
1. The Pharmaceutical Quality System
2. Personnel
3. Premises and Equipment
4. Documentation
5. Operations
6. Complaints, Returns, Suspected Falsified Medicinal Products and Medicinal Product Recalls
7. Outsourced Activities
8. Self Inspections
9. Transportation
10. Specific Provisions for Brokers
11. Final Provisions
As you can see, the inspec…