SOP for Inventory Management – Standard Operating Procedure
1) Purpose
To establish guidelines for the management and control of inventory to ensure adequate stock levels, minimize stockouts, optimize storage space, and maintain accurate inventory records within the pharmaceutical manufacturing department.
2) Scope
This SOP applies to the management of all inventory items, including raw materials, packaging materials, finished goods, and consumables used in pharmaceutical manufacturing and distribution.
3) Responsibilities
Warehouse Manager: Responsible for overseeing inventory management activities.
Production Planner: Responsible for forecasting inventory requirements based on production schedules.
4) Procedure
4.1) Inventory Planning:
4.1.1) Forecast inventory requirements based on production schedules, sales forecasts, and historical demand data.
4.1.2) Determine reorder points, safety stock levels, and lead times for each inventory item.
4.2) Inventory Receiving:
4.2.1) Receive incoming inventory items and verify against purchase orders and packing lists.
4.2.2) Inspect incoming materials for damage, quality issues, and compliance with specifications.
4.3) Inventory Storage:
4.3.1) Store inventory items in designated storage areas based on storage conditions and material compatibility.
4.3.2) Ensure proper labeling and segregation of materials to prevent mix-ups and cross-contamination.
4.4) Inventory Tracking and Control:
4.4.1) Use
4.4.2) Conduct regular cycle counts and physical inventories to reconcile system records with actual inventory.
4.5) Inventory Issuance:
4.5.1) Issue inventory items based on approved requisitions or production orders.
4.5.2) Document issuance transactions and update inventory records in real-time.
4.6) Inventory Disposal and Obsolescence:
4.6.1) Dispose of expired, damaged, or obsolete inventory items according to established procedures.
4.6.2) Review inventory regularly to identify and manage obsolete or slow-moving items.
5) Abbreviations, if any
N/A
6) Documents, if any
- Inventory Management Policy
- Inventory Reconciliation Reports
- Inventory Disposal Records
- Inventory Audit Findings
7) Reference, if any
Regulatory Guidelines: FDA CFR Part 211.80, ICH Q7
Industry Standards: ISO 9001:2015
8) SOP Version
Version 1.0
