SOP 13: Pharmacovigilance outsourced
This SOP defines how pharmacovigilance activities are outsourced, conducted, documented, and reported to ensure patient safety and regulatory compliance.
It outlines the process for collecting, evaluating, and reporting adverse events in accordance with GxP and EMA/FDA requirements.
The SOP is professionally written, pre-filled (≈ 99 % complete), and ready for implementation within your existing QMS framework.
This document provides a compliant structure for pharmacovigilance operations, ensuring traceability and readiness for authority inspections.
What’s included
1 SOP: Outsourced IMP Pharmacovigilance
✓ Editable Word documents✓ Prewritten GxP quality processes
✓ Ready for company specific customisation
✓ Designed to integrate with related QMS processes
✓ Suitable for paper based or electronic QMS implementation
Benefits
- Save weeks of documentation work
- Ensure consistent, GxP-aligned documentation
- Maintain controlled versions and effective dates
- Create traceable documentation and revision history
- Provide a scalable foundation for additional Quality processes
- Save weeks of documentation work
Suitable for
- Pharmaceutical companies building or expanding a QMS
- Early stage and growing regulated companies
- Virtual and highly outsourced companies
- Companies strengthening or standardising an existing Quality process
- Quality teams looking for ready to customise documentation
- Pharmaceutical companies building or expanding a QMS
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