GMP and GDP carry the same quality logic: defined processes, records and deviation handling. Where they separate is scope. GMP covers manufacture, quality control and the batch release by the responsible manager. GDP covers purchase, storage, shipment, export, returns and recall of the product; a manufacturer that distributes its own product therefore follows GDP too.
| GMP | GDP | |
|---|---|---|
| Who | The manufacturing site | The wholesaler and other parties in distribution |
| What it does to the product | Makes it, tests it, releases the batch | Buys, stores, ships it, manages returns and recall |
| Temperature band | Set from stability data of the product | Held in store and on the road, proved by records |
Delegating storage or transport does not delegate responsibility. Under the TİTCK GDP Guide the contract giver is responsible for outsourced activities, and each party's duties sit in a written contract. If a temperature deviation occurs in shipment, the guide requires the product's distributor and recipient to be told (section 10.2). Put temperature, records and deviation notification terms into the contract.
