SOP 10: Recall of investigational products
This SOP defines the end-to-end process for initiating, managing, and documenting product recalls or withdrawals in compliance with regulatory expectations.
It ensures timely, coordinated action to protect patient safety and maintain compliance with EMA, FDA, and GDP/GMP requirements.
The template is professionally written and pre-filled (≈ 98–99 % complete) and includes detailed roles and responsibilities for QA, logistics, and communication with authorities.
A robust recall procedure safeguards product quality, consumer safety, and your company’s regulatory reputation.
What’s included
1 SOP: Recall of investigational products
✓ 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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