Transportation validation shall be carried out for Finished Goods being transported to the destination(s) of distribution from the manufacturing unit.
During transportation, there is number of factors & conditions affecting the transportation, these factor to be kept under control and consider as a critical point for keeping safe the medicine, & for fulfillment of this purpose, transportation validation based on critical points as per dosage form required. Generally following points can be consider as validation factor but not limited to:
- Distance/geographical location of destination
- Storage Condition of Product
- Packing Configuration of Product
- Available stability data/report
- Mode of Shipment (air, train, road, sea, etc.)
- Any other specific consideration based on recommendation from supply chain or R&D departments
Based on this evaluation, Site QA shall prepare a list of products (category-wise) for which transportation validation is to be carried out.
In case there is a need for product-specific transportation validation, validation exercise shall be carried out individually.