1. Purpose: The purpose of this SOP is to provide standard operating procedures for the storage of raw material.
2. Scope: This SOP is applicable to all raw materials used in the production process.
3. Responsibilities:
3.1. The Quality Assurance (QA) department is responsible for ensuring that the raw materials are stored according to the SOP.
3.2. The Production department is responsible for the utilization of raw material as per requirement.
4. Procedure:
4.1. All raw materials should be inspected for damage or contamination before entering the warehouse.
4.2. Only approved raw materials should be stored in the warehouse.
4.3. The storage area should be clean and dry, with appropriate temperature and humidity control.
4.4. The raw materials should be stored in proper containers, labelled with their names, Lot number, date of receipt, expiry date, and other necessary information.
4.5. The storage area should be organized to ensure that the first-in-first-out (FIFO) principle is followed.
4.6. Materials with short expiry dates should be stored in a separate and easily accessible location.
4.7. Chemicals should be stored separately from other materials to avoid contamination or unwanted reactions.
4.8. Highly flammable or hazardous materials should be stored in designated areas and under appropriate safety precautions.
4.9. Regular monitoring of the storage area should be conducted to ensure the conditions are appropriate for the stored materials.
4.10. Handling and transportation of raw materials should follow procedures specified in other SOPs.
5. Documentation:
5.1. The QA department should keep records of the raw materials received.
5.2. The storage and handling of raw materials should be documented.
5.3. The QA department should maintain records of storage conditions and inventory of raw materials.
6. Training:
All personnel involved in the storage and handling of raw materials should be trained in the proper procedures outlined in this SOP.
7. References:
List all relevant laws, regulations, and policies that must be considered when storing Raw materials.
• FDA Guidance for Industry, Current Good Manufacturing Practice Requirements for Combination Products (2016)
8. Revision Record:
Version No. Date of Revision Reason for Revision
1.0 DD/MM/YYYY Initial version
