Standard Operating Procedure for Raw Material Storage
1) Purpose
The purpose of this SOP is to define the procedures for the proper storage of raw materials to ensure their quality and integrity are maintained until they are used in the manufacturing process.
2) Scope
This SOP applies to all raw materials stored in the warehouse and storage areas at [Company Name] used for manufacturing intramuscular, subcutaneous, and intravenous injection products.
3) Responsibilities
The responsibilities of this SOP include:
– Warehouse Personnel: Proper storage, handling, and monitoring of raw materials.
– Quality Assurance (QA): Routine checks and ensuring compliance with storage conditions.
4) Procedure
4.1 Storage Area Requirements
4.1.1 The storage area must be clean, dry, and well-ventilated.
4.1.2 Temperature and humidity conditions must be monitored and maintained within specified ranges.
4.2 Storage of Raw Materials
4.2.1 Raw materials must be stored on pallets or shelves, off the floor, and away from walls.
4.2.2 Each raw material must be clearly labeled with its name, batch number, and expiration date.
4.2.3 Materials must be stored according to their specific storage requirements (e.g., temperature-controlled areas for sensitive materials).
4.3 Inventory Management
4.3.1 The inventory system must be updated with each receipt and usage of raw materials.
4.3.2 Conduct regular inventory audits to ensure accurate stock levels and identify any discrepancies.
4.4 Handling of Raw Materials
4.4.1 Use proper material handling equipment to move raw materials to prevent damage and contamination.
4.4.2 Follow FIFO (First In, First Out) principle to ensure older stock is used first.
4.5 Monitoring and Documentation
4.5.1 Regularly monitor storage conditions and record temperature and humidity levels.
4.5.2 Maintain records of raw material receipts, storage conditions, and inventory levels.
5) Abbreviations, if any
– QA: Quality Assurance
– FIFO: First In, First Out
6) Documents, if any
– Raw Material Storage Log
– Temperature and Humidity Monitoring Records
– Inventory Audit Reports
7) Reference, if any
– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards
8) SOP Version
Version 1.0