GxP Services

Consulting, Qualification and Mapping

Expert support in the consulting, qualification and mapping service of trailers, equipment, warehouses and rooms. The products to be transported must remain within the given specifications throughout the entire distribution chain from the manufacturer to the end consumer. This applies both to refrigerated products and to products that should be stored at room temperature. We share our practice-oriented expert knowledge and know-how with you.

Consulting Services

Our customers rely on our expertise in the pharmaceutical environment and GxP compliance. The ELPRO team consults you on GDP/GMP regulations and ISO requirements. We support you in improving processes, under consideration of a risk management, to ensure the quality of the medicinal products.

Qualification

Our qualification services ensure that your transport vehicle, equipment, storage and production facilities meet the GxP standards. We offer complete qualification according to the V-model, from risk assessments, DQ, IQ, OQ to PQ, to ensure the quality of active ingredients, excipients, packaging materials and medicinal products.

GxP Temperature and Humidity Mapping

Part of the qualification process is temperature mapping, which proves whether the transport vehicle, equipment, production or storage building is suitable for your specific requirements. The services from ELPRO offer detailed temperature and relative humidity mapping to ensure product quality and regulatory compliance. You can choose between on-site mapping services, remote mapping services or do-it-yourself mapping kits, which ELPRO has developed for ULT freezers, small refrigerators and freezers up to 2 m³ as well as small rooms (up to. 18 x 18 m) and large refrigerators/freezers up to 20 m³.