DRUG REGULATORY ORGANIZATIONS
gdp (good distribution practice)
Rules that ensure that products and goods are handled and transported in accordance with all necessary conditions taking into account the nature of the product, in order to ensure that the product reaches the final consumer free of changes.
PHARMACEUTICAL DISTRIBUTION MODEL
- Product Tracking;
- Product Segregation (Contamination);
- Cold Chain reassurance;
- Validated and Audited Stakeholders.
- Active cooler (envirotainer);
- Airport Handling;
- Transference between Warehouse and Appliance;
- Airplane temperature while travelling;
- Temperatures Validation by the Airline Company.
- Shipping companies do not provide temperature recording.
- Isothermal volumes with gel packs and dry ice.
- Container that allows to produce cold with the help of an engine, powered by batteries or connected to the electric current;
- Cold origin: Electrical or dry ice.
CONVENTIONAL TEMPERATURES -18ºC +2ºC to +8ºC +15ºC to +25ºC +2ºC to +25ºC
AIRLINES AND SERVICES
- The temperature is guaranteed only during the flight;
- The temperature is not guaranteed during the loading and unloading phases of the devices;
- Due to the boarding time limit, the placement in a temperature controlled chamber in the airline is not guaranteed on departure.