Minimum and Maximum Stock Levels – Standard Operating Procedure

1) Purpose

To establish guidelines for setting and maintaining minimum and maximum stock levels to ensure optimal inventory management, prevent stockouts, and avoid overstocking within the pharmaceutical manufacturing department.

2) Scope

This SOP applies to all inventory items, including raw materials, packaging materials, finished goods, and consumables used in pharmaceutical manufacturing and distribution.

3) Responsibilities

Production Planner: Responsible for determining stock levels based on production schedules and demand forecasts.
Warehouse Manager: Responsible for monitoring and adjusting stock levels to maintain balance between supply and demand.

4) Procedure

4.1) Stock Level Assessment:
4.1.1) Analyze historical consumption data, production schedules, and demand forecasts to determine optimal stock levels.
4.1.2) Consider factors such as lead times, storage capacity, and economic order quantities (EOQ).

4.2) Minimum Stock Levels:
4.2.1) Set minimum stock levels based on consumption rates, lead times, and safety stock requirements.
4.2.2) Ensure minimum stock levels are sufficient to prevent stockouts during normal operations.

4.3) Maximum Stock Levels:
4.3.1) Establish maximum stock levels to avoid overstocking and minimize carrying costs.
4.3.2) Consider shelf life, storage conditions, and production capacity when setting maximum stock limits.

4.4) Stock Monitoring:
4.4.1) Monitor stock levels regularly using inventory management systems or manual checks.
4.4.2) Adjust stock levels as needed to maintain optimal inventory levels and avoid shortages or excess.

4.5) Replenishment Adjustments:
4.5.1) Review and update minimum and maximum stock levels periodically based on changing demand patterns or operational requirements.
4.5.2) Obtain necessary approvals for adjustments from authorized personnel.

4.6) Reporting and Documentation:
4.6.1) Document minimum and maximum stock levels for each inventory item in inventory control records.
4.6.2) Generate reports on stock level deviations and adjustments for management review.

5) Abbreviations, if any

EOQ – Economic Order Quantity

6) Documents, if any

• Stock Level Setting Forms
• Inventory Control Records
• Stock Level Adjustment Requests
• Management Reports on Stock Levels

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211.80, ICH Q10
Industry Standards: ISO 13485:2016

8) SOP Version

Version 1.0