1. Purpose: The purpose of this Standard Operating Procedure (SOP) is to define the raw material handling procedures in a way that ensures safety and quality, minimizes cross-contamination, and facilitates the movement of raw materials from receiving to storage and production areas.
2. Scope: This procedure applies to all raw materials received, handled, and stored at XYZ Company.
3. Procedure:
Step 1: Receiving of Raw Materials: All raw materials received shall be inspected for their condition, quality, and quantity as per the specifications defined in the purchase order. The receiving team shall follow the following steps:
• Ensure that the receiving area is clean and free of contaminants.
• Receive the shipment according to the purchase order.
• Inspect the raw materials for damage, leaks, deterioration, or any other irregularities.
• Verify the quantity of raw materials received and update it in the inventory system.
• Collect relevant documents, such as a certificate of analysis or a safety data sheet.
Step 2: Storage of Raw Materials: Raw materials shall be stored safely and in accordance with their storage requirements. The following steps shall be followed:
• Allocate designated storage areas for each raw material according to its storage requirements and shelf-life specifications.
• Store the raw materials in a clean, dry, well-ventilated, and labeled area.
• Ensure that the storage area has appropriate temperature and humidity control.
• Maintain minimum and maximum inventory levels for each raw material in the inventory system.
• Use the FIFO method (first in, first out) to ensure that the oldest stock is used first.
Step 3: Handling of Raw Materials: Raw materials shall be handled with care and in a way that minimizes contamination and safety risks. The following steps shall be followed:
• Use clean, sanitized, and properly labeled equipment for handling raw materials.
• Ensure that the handling equipment is appropriate for the type and quantity of raw material.
• Wear personal protective equipment (PPE) as per the specifications of the raw material.
• Follow the proper lifting and handling techniques to avoid injury.
• Use dedicated equipment for each raw material to avoid cross-contamination.
Step 4: Disposal of Raw Materials: All raw materials that are damaged, expired, or no longer needed shall be disposed of safely and in accordance with regulations. The following steps shall be followed:
• Identify the raw materials that need to be disposed of by checking the inventory system.
• Dispose of the raw materials according to the regulations defined by the local authorities.
• Take precautionary measures to avoid any environmental contamination or safety hazards.
• Record the disposal of each raw material in the inventory system.
4. Responsibilities: The following employees are responsible for implementing and following this Raw Material Handling Procedure:
• Receiving team
• Production team
• Quality Assurance team
• Warehouse team
5. Definitions: FIFO – First in, First out; PPE – Personal Protective Equipment
6. References: Relevant regulations and guidelines governing the handling of raw materials, including but not limited to, Current Good Manufacturing Practices (cGMPs).
7. Revision History: This SOP shall be reviewed and updated annually or as needed by the Quality Assurance team.