SOP-21: Final Product Item Number defines the system for creating and controlling the unique item number assigned to your company’s finished pharmaceutical product. This identifier links all outsourced manufacturing, testing, warehousing, and distribution activities to one consistent product entity, ensuring full traceability, correct documentation, and GMP/GDP compliance.
 
This SOP is professionally written and pre-filled (~95% complete), requiring only company-specific details before approval.
Developed for companies relying on external CMOs, laboratories, and distributors, the template outlines how item numbers are generated, communicated, and maintained — and how changes to formulation, packaging, or configuration trigger reassignment. It also defines responsibilities for QA, Supply Chain, and the Qualified Person (QP).
 
Includes:
• Structure and coding format for product item numbers
• Rules for creation, maintenance, and documentation
• Requirements for communication to CMOs, labs, and logistics partners
• Use of item numbers across batch documentation and labels
• Change control expectations for item number updates
 
Why it matters:
A controlled item numbering system is essential for regulatory compliance, partner alignment, and accurate batch documentation. This SOP ensures your organisation maintains consistent product identification throughout the entire outsourced supply chain.