SOP-14: Prevention and Management of Counterfeit Medicines provides a complete, inspection-ready procedure for preventing, detecting, and managing suspected counterfeit medicinal products.
 
It outlines how your company identifies suspicious products, quarantines them, conducts investigations, communicates with authorities, and implements corrective actions — ensuring full compliance with EMA, FDA, and EU GMP requirements.
 
This SOP is professionally written and pre-filled (~95% complete), requiring only company-specific details before approval.
Developed by QA specialists with real-world GMP experience, it reflects regulatory expectations for Marketing Authorisation Holders and organisations outsourcing manufacturing, packaging, testing, or distribution.
 
Includes:
• Prevention and detection measures
• Roles and responsibilities across QA, contractors, and operations
• Investigation process and documentation requirements
• Reporting to Medicines Agencies
• Quarantine handling and recall integration
• CAPA actions to prevent recurrence
 
Why it matters:
Counterfeit medicinal products are a major regulatory and patient-safety risk. Authorities expect robust prevention and rapid escalation procedures. This pre-filled SOP helps your organisation meet those expectations and maintain full oversight of your supply chain.