Warehouse Management Procedures for MDI Production
1) Purpose
The purpose of this SOP is to establish procedures for warehouse management in metered-dose inhaler (MDI) production to ensure efficient storage, handling, and control of raw materials, components, and finished products.
2) Scope
This SOP applies to all warehouse areas within the MDI production facility, including raw materials, packaging materials, intermediate products, and finished goods storage.
3) Responsibilities
The responsibilities for this SOP include inventory control, storage practices, material handling, and compliance with regulatory requirements.
4) Procedure
4.1 Warehouse Layout and Design
4.1.1 Designate specific storage areas for raw materials, components, intermediate products, and finished goods.
4.1.2 Ensure adequate space, shelving, and segregation based on material compatibility and storage requirements.
4.2 Receipt and Inspection of Materials
4.2.1 Receive incoming materials and verify against purchase orders, including quantity, specifications, and documentation requirements.
4.2.2 Conduct visual inspection and quality checks to ensure materials meet acceptance criteria before storage.
4.3 Storage Conditions
4.3.1 Store materials according to specified conditions (e.g., temperature, humidity, light exposure) as per product requirements and regulatory guidelines.
4.3.2 Monitor storage conditions regularly and implement controls to prevent mix-ups, cross-contamination, or deterioration.
4.4 Inventory Management
4.4.1 Maintain accurate inventory records, including receipts, withdrawals, and stock levels using a designated inventory management system.
4.4.2 Conduct periodic physical inventory counts and reconciliation with electronic records to ensure accuracy.
4.5 Material Handling and Distribution
4.5.1 Implement procedures for safe handling, labeling, and transportation of materials within the warehouse.
4.5.2 Ensure proper documentation and traceability of materials during distribution to production areas or shipment to customers.
4.6 Environmental Controls
4.6.1 Monitor and control environmental factors such as temperature, humidity, and cleanliness to prevent adverse effects on stored materials.
4.6.2 Implement pest control measures and maintain cleanliness to minimize risks of contamination.
4.7 Documentation and Records
4.7.1 Maintain detailed records of warehouse operations, including receipts, inspections, storage conditions, inventory transactions, and distribution activities.
4.7.2 Document any deviations from warehouse procedures and corrective actions taken to address them.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
6) Documents, if any
Warehouse layout plans, inventory records, inspection reports, environmental monitoring logs, and material handling procedures should be maintained as part of the warehouse management system.
7) Reference, if any
Refer to warehouse management guidelines from regulatory agencies, industry standards (e.g., GDP), and internal quality management procedures.
8) SOP Version
Version 1.0
