Factor Affecting Transportation of Pharma dosages – validation points

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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.

 

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