Product/Service

Environmental Mapping Qualification

Environmental Mapping Qualification

Vaisala offers comprehensive mapping qualification solutions to help you to comply with the GDP (Good Distribution Practice) regulations such as EU GDP (2013/C 343/01) and USP 36 Chapter <1079> and the forthcoming <1083>. Environmental mapping qualifications — necessary in areas that store human and investigational medicinal products — are performed by drug manufacturers, storage facilities, wholesale distributors and other stakeholders in the GxP supply chain.

Vaisala Environmental Mapping Qualification offerings includes:

  • Mapping kit : Vaisala data loggers, vLog software to collect the measurement data, and the vLog IQ/OQ protocol to validate the software according to 21 CFR Part 11 and Annex 11
  • World-class mapping services to profile the temperature and relative humidity dynamics of refrigerators, freezers, cold rooms, warehouses, storage areas, distribution centers, incubators, or stability chambers. (Service available in Europe, Japan and China.)
  • Optional data logger rentals , an economical option for industry-best accuracy