GxP Services for logistics & shipping
The protection of product quality during transport and storage of, for example, medicines is an important and essential component of the GxP directive. The basis for observance of legal regulations is GxP-compliant qualification of the transport equipment or storage facility. The ROTRONIC After Sales Service has specialized in these services and offers you an efficient solution tailored exactly to your requirements. Temperature mapping service available (warehouses, production rooms, climate cabinets, climate chambers, trucks, etc.).
Typical mapping applications: production & storage in the pharmaceutical industry, food industry and wherever temperature sensitive products are stored.
ROTRONIC will discuss the modules needed for qualification with you and propose the best possible time schedule for the qualification procedure. Thanks to the modular structure of this service, you only pay for the qualification steps you need; this approach has proven itself in many reference projects and has also found favor with our customers worldwide. A ROTRONIC qualification engineer will explain and substantiate the GxP-compliant data directly on customer request in the case of an possible audit.
- Warehouse qualification & validation (climate mapping)
- Transport qualification
- Climate chamber mapping
- Maintenance & installation of the measuring systems
- On-site calibrations
- Exact data on the climate in the room
- Mapping conforming to FDA & GxP
- Knowledge of possible danger zones in the controlled climate