GDP mapping – general information
Offering temperature mapping testing of the cargo space of vehicles designed to carry medicinal products.
The Health Minister's regulation on Good Distribution Practice for medicinal products imposes an obligation on wholesale traders of these products, among other things, to map the temperature of the cargo space of vehicles intended for transporting these products.
Central Refrigeration Center "COCH" offers studies of the temperature distribution (so-called mapping) of the interior of thermally insulated bodies with a refrigeration or refrigeration-heating unit installed, for single- or multi-compartment means of transport, for winter and summer.
The COCH laboratory is accredited for testing in accordance with PKN-DIN SPEC 91323:2019-08 "Temperature-controlled commercial vehicles used for distribution of pharmaceutical products (for human or veterinary use) -- Qualification guidelines".
- Tests of temperature distribution inside the body without loading;
- Tests of temperature distribution inside the body with loading.
On the basis of the above-mentioned research, the temperature distribution (temperature map) inside the means of transport is determined, along with the identification of places with minimum and maximum temperature, and the comparison of the temperature measurement results obtained with the temperatures read by the sensors on the equipment of the means of transport.
The Refrigeration Center has a climate chamber that provides the ability to simulate transport conditions for the summer season (ambient temperature of +30°C) and winter season (ambient temperature of -20°C), for means of transport of various dimensions.
- Geometric dimensions: length 22m, height 4.6m, width 4m;
- Temperature control range: from -20°C to +40°C;
- Relative humidity control range: from 20% to 90%;
- Air velocity control range: from 0 m/s to 4 m/s.
- Effect of door opening on temperature distribution inside the body;
- Simulation of genset failure or power outage;
- Time required to achieve the desired temperature inside the body (set on the controller);
- Others (to be agreed with the Customer).
Details on EU GDP certification and mapping
The EU GDP Guidelines (Guidelines of November 5, 2013 on good distribution practice for medicinal products for human use – 2013/C 343/01) list special requirements for temperature-sensitive products in Chapter 2.4. and Chapter 9.4:
- Section 2.4 (Training): “[…] Personnel handling any products that require more stringent handling conditions should receive special training. Examples of such products include […] temperature-sensitive products.
A record should be kept of all training, and the effectiveness of the training should be periodically evaluated and documented.”
- Section 9.4 (Products requiring special conditions): “[…] For temperature-sensitive products, qualified equipment (e.g., thermal packaging, temperature-controlled containers, or temperature-controlled vehicles) should be used to ensure that proper transportation conditions are maintained between the manufacturer, the wholesale distributor, and the customer.
If temperature-controlled vehicles are used, temperature monitoring equipment used during transportation should be maintained and calibrated at regular intervals. Temperature mapping should be carried out under representative conditions and take into account seasonal changes.
Upon request, customers should be provided with information confirming that products have met temperature storage conditions. […]
The process for delivering sensitive products and controlling seasonal temperature changes should be described in a written procedure.”