Outsourced Activities and Contractual Oversight SOP
Oversight of third-party logistics and contracts.
3 000 Skr
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Purpose:
This SOP defines the requirements for the qualification, contractual control, and ongoing oversight of outsourced activities and service providers, including third-party logistics providers (3PLs), to ensure continued compliance with GDP and GMP requirements.
Regulatory Alignment:
EU Guidelines on Good Distribution Practice (2013/C 343/01) and EU GMP requirements for outsourced activities, contractual arrangements, and delegation of responsibilities.
Included Files:
• SOP – Outsourced Activities and Contractual Oversight
• Outsourced activity risk assessment template
• Contract and quality agreement review checklist
• Oversight and performance review record
Format:
Microsoft Word (fully editable)
Intended Users:
Wholesale distributors, marketing authorisation holders, Responsible Persons, quality assurance teams, and personnel responsible for managing outsourced GDP/GMP activities and contractual relationships.