Returns, Recalls, and Falsified Medicines Handling SOP
Returns and recalls procedure.
3 200 Skr
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Purpose:
This SOP defines the requirements for the management of returned medicinal products, execution of product recalls, and handling of suspected or confirmed falsified medicines to protect patient safety and maintain supply chain integrity.
Regulatory Alignment:
EU Guidelines on Good Distribution Practice (2013/C 343/01) and applicable requirements related to falsified medicines handling and product recall management.
Included Files:
• SOP – Returns, Recalls, and Falsified Medicines Handling
• Product return assessment and decision record
• Recall execution and communication template
• Falsified medicines reporting and segregation record
Format:
Microsoft Word (fully editable)
Intended Users:
Wholesale distributors, marketing authorisation holders, Responsible Persons, quality assurance teams, and personnel involved in GDP-regulated distribution and recall activities.