Transport Qualification and Shipping Oversight SOP
Qualification of transport routes and packaging.
3 800 Skr
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Purpose:
This SOP defines the requirements for qualification, approval, and ongoing oversight of transport and shipping activities to ensure medicinal products are distributed under controlled and compliant conditions.
Regulatory Alignment:
EU Guidelines on Good Distribution Practice (2013/C 343/01), including expectations for transport qualification, shipping controls, documentation, and management of temperature excursions and deviations.
Included Files:
• SOP – Transport Qualification and Shipping Oversight
• Transport qualification assessment template
• Shipping deviation and excursion reporting form
Format:
Microsoft Word (fully editable)
Intended Users:
Wholesale distributors, marketing authorisation holders, Responsible Persons, logistics oversight teams, and quality assurance personnel involved in GDP-regulated transport and distribution activities.