SOP-19: Return and Destruction of Medical Products describes the controlled, compliant handling of returned medicinal products and the secure destruction of products that cannot be released or reused. It ensures full traceability, regulatory compliance, and prevention of unauthorized reintroduction into the market.
 
This SOP is professionally written and pre-filled (~95% complete), requiring only company-specific details before approval.
Developed for organisations working with external distributors and destruction providers, the template outlines responsibilities for QA, contractors, and licensed waste handlers. It includes requirements for quarantine, evaluation of returned goods, rejection criteria, destruction orders, and documentation such as destruction certificates.
 
Includes:
• Rules for receiving and logging returned products
• QA evaluation criteria (storage history, condition, expiry, cold chain issues)
• Requirements for rejection vs. exceptional re-use
• Destruction Order template and approval flow
• Use of licensed destruction providers and documentation
• Traceability, reconciliation, and archiving requirements
 
Why it matters:
Improper return or destruction handling poses major regulatory and safety risks. This SOP ensures your company follows a compliant, fully documented process that prevents misuse, protects product integrity, and meets GMP/GDP expectations.