EU GDP Guidelines 2013/C 343/01
Guidelines on Good Distribution Practice of medicinal products for human use. Chapter 9 governs transportation: maintaining conditions, documenting them, and handling deviations.
EU GDP Guidelines 2013/C 343/01 require that the storage and transport conditions of a medicinal product are documented and reviewable, and Annex 15 requires that the equipment doing it is qualified and revalidated. We generate that documentation as the shipment moves, from the same records our own quality manager works from.
Guidelines on Good Distribution Practice of medicinal products for human use. Chapter 9 governs transportation: maintaining conditions, documenting them, and handling deviations.
Equipment that keeps a product in its conditions has to be qualified and requalified on a defined cycle. That is why our mapping and calibration run annually and are tracked with expiry.
Held by UAB Transpharmacia, company code 300662544, in the register of the Lithuanian State Medicines Control Agency. Ask us and we send the authorisation record with the entity details above.
A methodology is only worth naming if each pillar is enforced by software. Each of these is a behaviour of the platform, and each one leaves a record.
Annual temperature mapping per vehicle, annual calibration per logger, and a pre-trip qualification check per consignment. An asset whose certificate has expired cannot be assigned.
Telemetry is sliced by vehicle, by the zone your pallets rode in and by the window between loading and delivery, so the record follows the consignment rather than the truck.
A breach past the grace period opens a deviation record automatically, notifies the dispatcher and the Responsible Person, and cannot be closed without a recorded root cause and CAPA.
Certificate, custody timeline, CMR, seal photographs, ePOD and any deviation statement arrive as one pack when custody closes.
Qualification that happened once is not qualification. Three cycles run continuously and all three are visible on the quality dashboard before an auditor could ask.
12 vehicles carry a temperature mapping and qualification record with an expiry date.
12 calibration certificates are on file, and expiry turns the asset red 30 days ahead.
Assignment is blocked when a vehicle zone cannot legally hold the consignment's regime, so the check happens before loading rather than after an audit.