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GDP, DPD mapping

We provide temperature distribution mapping services for transport vehicles for medical products, in accordance with the Good Distribution Practice (GDP) guidelines of the Ministry of Health of the Republic of Poland. These tests are carried out in accordance with PKN-DIN SPEC 91323:2019-08 and include temperature mapping both loaded and unloaded, using a specialized climate chamber that simulates summer and winter conditions.

Details on EU GDP certification and mapping

EU GDP Guidelines

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:

  • Chapter 2.4 (Training): “Personnel handling any products that require more rigorous handling conditions should undergo specialized training. Examples of such products include those sensitive to temperature. A record of all training sessions must be maintained, and the effectiveness of training should be periodically assessed and documented.”

  • Chapter 9.4 (Products Requiring Special Conditions): “For temperature-sensitive products, qualified equipment should be used (e.g., thermal packaging, containers with controlled temperature, or vehicles with temperature control) to ensure proper transport conditions between the manufacturer, wholesale distributor, and customer. When using temperature-controlled vehicles, temperature monitoring equipment used during transport should be serviced and calibrated at regular intervals. Temperature mapping should be conducted under representative conditions and should account for seasonal variations. Upon request, customers should receive information confirming that products met storage temperature conditions. The process for delivering temperature-sensitive products and monitoring seasonal temperature changes should be documented in a written procedure.”


Quality accreditation - a guarantee of trust

The AB 308 Refrigeration Equipment Laboratory is accredited by the Polish Accreditation Center and specializes in testing refrigeration equipment.

Our team consists of qualified and experienced specialists who offer comprehensive assistance in the process of preparation for testing and the refrigeration equipment tests themselves. With our services, we provide customers with reliable and professional service at every stage of cooperation.

Contact information

Below you will find a list of contact information for COCH Refrigeration Equipment Laboratory

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