Stock Replenishment Planning – Standard Operating Procedure

1) Purpose

To establish guidelines for planning and executing stock replenishment activities to ensure optimal inventory levels, prevent stockouts, and support uninterrupted production within the pharmaceutical manufacturing department.

2) Scope

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

3) Responsibilities

Production Planner: Responsible for forecasting inventory requirements and initiating replenishment orders.
Procurement Team: Responsible for sourcing and procuring inventory items in accordance with replenishment plans.

4) Procedure

4.1) Inventory Analysis:
4.1.1) Monitor inventory levels and consumption patterns through regular analysis and reports.
4.1.2) Identify items approaching minimum stock levels or reorder points.

4.2) Replenishment Trigger:
4.2.1) Determine replenishment triggers based on inventory thresholds, lead times, and consumption rates.
4.2.2) Initiate replenishment orders when inventory levels reach predetermined triggers.

4.3) Requisition and Approval:
4.3.1) Create purchase requisitions or production orders based on replenishment requirements.
4.3.2) Obtain necessary approvals for replenishment orders from authorized personnel.

4.4) Supplier Communication:
4.4.1) Communicate replenishment requirements to approved suppliers or internal production teams.
4.4.2) Provide detailed specifications, quantities, and delivery timelines to ensure timely procurement.

4.5) Order Processing:
4.5.1) Process purchase orders or production orders in accordance with approved requisitions.
4.5.2) Monitor order status and expedite as necessary to meet production and inventory goals.

4.6) Documentation and Tracking:
4.6.1) Maintain records of replenishment orders, including order details, approvals, and delivery confirmations.
4.6.2) Track and report on replenishment performance metrics, such as order lead times and supplier reliability.

5) Abbreviations, if any

N/A

6) Documents, if any

• Replenishment Order Forms
• Purchase Requisitions
• Production Orders
• Supplier Performance Reports

7) Reference, if any

Regulatory Guidelines: FDA CFR Part 211.80, ICH Q9
Industry Standards: ISO 9001:2015

8) SOP Version

Version 1.0