Distribution & Cold Chain (GDP)
Protecting product quality after release — through storage, transport, and the supply network.
Product quality can be lost after it leaves the manufacturing site. Temperature excursions in transport and trading with unqualified supply partners are frequent Good Distribution Practice findings — and a cold-chain failure can quietly compromise a product that passed every release test.
The observable evidence a practitioner — or an inspector — would expect at each maturity level. Drawn from the assessment questions themselves.
How is temperature control maintained across storage and transport?
Storage monitored; transport largely unmonitored
Temperature mapping done once; transport spot-checked
Qualified storage plus monitored transport with MKT-based excursion evaluation per EU GDP
End-to-end continuous monitoring with automated excursion alerts and trending
End-to-end predictive cold chain: continuous monitoring, automated MKT excursion modelling, and ongoing route / lane optimisation
How are distribution suppliers and customers qualified?
Minimal checks before trading
Initial bona-fide checks that are not routinely refreshed
Documented qualification with periodic re-checks per GDP
Risk-scored supply-chain qualification integrated with falsified-medicine controls
Continuously risk-scored supply network with automated bona-fide verification and integrated anti-falsification controls
- ›Transport not temperature-monitored or qualified; no MKT-based excursion evaluation.
- ›Storage areas not temperature-mapped, or monitoring with coverage gaps.
- ›Suppliers and customers not qualified (bona-fide checks), or not periodically re-verified.
- ›Weak controls against falsified medicines and inadequate handling of returns.