Inventory Management – Standard Operating Procedure

1) Purpose

To establish a standardized process for managing inventory levels effectively, ensuring adequate stock availability while minimizing excess inventory within the pharmaceutical purchase department.

2) Scope

This SOP applies to all inventory management activities, including stock monitoring, replenishment, storage, and inventory record-keeping.

3) Responsibilities

Inventory Manager: Responsible for overall inventory management and adherence to this SOP.
Inventory Team: Responsible for daily stock monitoring, replenishment, and inventory accuracy.
Procurement Team: Responsible for coordinating with suppliers to ensure timely replenishment of inventory.

4) Procedure

4.1) Stock Monitoring:
4.1.1) Use inventory management software/systems to track stock levels in real-time.
4.1.2) Conduct regular physical counts and reconcile with inventory records to identify discrepancies.
4.1.3) Set up automatic alerts for low stock levels to initiate replenishment.

4.2) Replenishment Process:
4.2.1) Forecast demand based on historical data, production schedules, and sales forecasts.
4.2.2) Generate purchase requisitions or orders to replenish inventory based on forecasted demand.
4.2.3) Coordinate with the procurement team to ensure timely placement of orders with approved suppliers.

4.3) Storage and Handling:
4.3.1) Store inventory items in designated storage areas based on storage requirements (e.g., temperature, humidity).
4.3.2) Implement FIFO (First In, First Out) or FEFO (First Expired, First Out) methods to manage inventory rotation.
4.3.3) Ensure proper handling and labeling of inventory to prevent damage or deterioration.

4.4) Inventory Record-Keeping:
4.4.1) Maintain accurate and up-to-date inventory records, including item descriptions, quantities, locations, and expiration dates (if applicable).
4.4.2) Regularly reconcile physical inventory counts with recorded inventory levels.
4.4.3) Document any adjustments or discrepancies in inventory records promptly.

4.5) Inventory Optimization:
4.5.1) Analyze inventory turnover rates and adjust stock levels to optimize inventory carrying costs.
4.5.2) Implement continuous improvement initiatives to streamline inventory processes and reduce stock-outs.
4.5.3) Conduct periodic reviews of inventory management practices to identify opportunities for improvement.

5) Abbreviations, if any

• FIFO: First In, First Out
• FEFO: First Expired, First Out

6) Documents, if any

• Inventory Reports
• Purchase Requisitions/Orders
• Inventory Adjustment Forms
• Stock Count Sheets

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211, GMP Guidelines
Industry Standards: Best practices in inventory management

8) SOP Version

Version 1.0