GDP for Cold Chain Compliance
Good Distribution Practice (GDP) is a benchmark and a compliance requirement for the pharma industry, including manufacturers and their subcontractors. Good cold chain monitoring is a sure-fire way to ensure compliance.
To be compliant, products must retain conformity and integrity from the moment the product leaves the manufacturer and all through the supply chain, to the end customer. Therefore, regular auditing is a necessity.
There are three key aspects to achieving cold chain compliance in transit: the equipment, the service, and transport conditions.
When it comes to the equipment used to secure and maintain temperature control, it must have GDP compliant validation. This includes insulated packaging, refrigerated cabinets, and cold rooms, as well as any devices used before shipping, in transit, or upon arrival.
A data logger is one such device, and the GxP compliant and calibrated LIBERO G is a fine example. The real-time temperature data logger and position tracker is FDA 21 CFR Part 11 compliant, with ISO 17025 calibrated sensors.
Likewise, operational teams must achieve GxP qualification. Training on temperature-sensitive product management is essential, and they should use equipment designed specifically for temperature control.
Finally, transportation conditions can interfere with compliance, so every shipment should come with a well-prepared route analysis. Seasonal variations are likely, and the best way to prevent mismanagement is to carry out trial shipments.