Supplier Qualification and Oversight SOP
Supplier assessment, qualification and monitoring.
4 500 Skr
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Purpose:
This SOP defines the process for qualification, approval, monitoring, and ongoing oversight of suppliers and outsourced service providers that may impact product quality, regulatory compliance, or GxP activities.
Regulatory Alignment:
EU GMP and EU GDP requirements for outsourced activities, supplier qualification, quality agreements, and ongoing performance monitoring.
Included Files:
• SOP – Supplier Qualification and Oversight
• Supplier qualification questionnaire
• Supplier approval and review checklist
• Supplier performance review template
Format:
Microsoft Word (fully editable)
Intended Users:
Pharmaceutical companies, marketing authorisation holders, manufacturers, distributors, and quality assurance teams responsible for managing suppliers and outsourced activities.