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.
Includes:
•Recall initiation and classification (Class I–III)
•Communication procedures with competent authorities and partners
•Product identification, reconciliation, and traceability
•Recall reporting and documentation templates
•Post-recall evaluation and CAPA integration
A robust recall procedure safeguards product quality, consumer safety, and your company’s regulatory reputation.