Standard Operating Procedure for Inventory Control in Gels Production
1) Purpose
The purpose of this SOP is to establish procedures for the systematic management and control of inventory related to raw materials, intermediates, and finished products within the gels production department, ensuring accuracy, traceability, and compliance with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in inventory control activities within the pharmaceutical manufacturing facility’s gels production department.
3) Responsibilities
Inventory Control Manager: Oversee inventory management and implement procedures outlined in this SOP.
Quality Assurance (QA) Team: Monitor inventory processes and ensure compliance with quality standards.
Production Supervisors: Provide accurate inventory data for production planning and scheduling.
4) Procedure
4.1 Inventory Classification
4.1.1 Classify inventory items into categories such as raw materials, packaging materials, intermediates, and finished products.
4.1.2 Assign unique identification codes or numbers to each inventory item for tracking purposes.
4.2 Receipt and Verification
4.2.1 Receive incoming materials and products according to approved purchase orders or production plans.
4.2.2 Verify received quantities against documentation and conduct visual inspection for damage or discrepancies.
4.3 Storage and Handling 4.4 Inventory Tracking and Recording 4.5 Inventory Reconciliation SOP: Standard Operating Procedure – Inventory Control Procedures Manual – FDA Guidance for Industry: Current Good Manufacturing Practice for Finished Pharmaceuticals Version 1.0
4.3.1 Store inventory items in designated areas based on storage conditions and material compatibility.
4.4.1 Use inventory management software or manual systems to record all transactions including receipts, issues, transfers, and adjustments.
4.4.2 Maintain accurate and up-to-date inventory records to reflect current stock levels and locations.
4.5.1 Perform regular cycle counts and physical inventory audits to reconcile physical inventory with recorded quantities.
4.5.2 Investigate and resolve discrepancies identified during inventory reconciliation processes.5) Abbreviations, if any
QA: Quality Assurance6) Documents, if any
– Inventory Reconciliation Reports
– Inventory Management Software Documentation7) Reference, if any
– EU GMP Part II: Basic Requirements for Active Substances Used as Starting Materials
– Company-specific inventory control procedures and guidelines8) SOP Version
