Transport Verification Protocols (TVP)
Transport verification protocols were created for all transport routes to be carried out.
Carrying out the transport
The data loggers were attached to the goods at the specified points (in accordance with the packaging specification), the transport was carried out and the data loggers were evaluated after transport.
Transport Verification Reports (TVB)
The reports described all activities and observations during the execution of the transport verification according to the TVMP and the TVP. The test results of the transport process were evaluated with regard to the transport hazards such as temperature and mechanical stress (e.g., vibration, shock, temperature) and their possible impacts on the physical integrity of the product packaging (e.g., damage to the cartons). It was demonstrated that all identified risks of the risk assessment and the necessary measures were covered during the transport verification (keyword: traceability).
GMP-compliant documentation
All required documents had to be created, approved and made available before the transport was carried out. After carrying out the transport, all documents had to be evaluated and processed in accordance with GMP.