With the increased regulatory focus on validation and qualification, we follow best practice guidelines to write and execute appropriate protocols to meet regulatory requirements. We manage the entire process from start to finish and provide an audit ready validation/ qualification protocol and report with all supporting evidence.
Warehouses (15 °C to 25 °C)
Freezers (-20 °C to -80 °C)
Fridge and Cold-rooms (2°C to 8 °C)
Supply Chain Vehicles (Fine Distribution and Line Haul Vehicles)
Hot Tunnels and Stability Chambers
11.4.1. The following should be validated as a minimum: (a) Warehouse premises: ambient and cold-chain storage conditions including temperature mapping; (b) Lagged containers; (c) Cold-chain processes; (d) Computerised systems; and (e) Transportation systems
184.108.40.206. (a) Packaging system of thermolabile pharmaceutical products, for purposes of distribution must be quality assured to ensure that it occurs within the cold room environment, fulfils the manufacturers’ specifications requirements, is thermally designed and validated, and is related to Temperature Profile(s)/Logistic history.