1) SOP for Material Handling and Storage

2) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the proper handling, storage, and labelling of raw materials and intermediates to prevent contamination, mix-ups, and ensure product quality and safety.

3) Scope

This SOP applies to all personnel involved in the handling, storage, and labelling of raw materials and intermediates within the pharmaceutical manufacturing facility.

4) Responsibilities

• Warehouse personnel are responsible for the correct handling, storage, and labelling of materials according to this SOP.
• Quality Assurance (QA) personnel are responsible for verifying that materials are handled and stored properly.
• Supervisors are responsible for overseeing material handling and storage processes to ensure compliance with this SOP.

5) Procedure

1. Receiving and Handling Materials
   1. Upon receipt of raw materials and intermediates, inspect the containers for any signs of damage or contamination.
   2. Verify the material’s identity and quantity against the purchase order and accompanying documentation.
   3. Record the receipt details in the inventory management system.
   4. Use appropriate equipment and techniques for handling materials to prevent damage and contamination.
   5. Wear appropriate personal protective equipment (PPE) as specified in the SOP.
2. Storage of Materials
   1. Store materials in designated storage areas that are clean, dry, and temperature-controlled as per material specifications.
   2. Segregate materials based on their status (e.g., quarantined, released, rejected) and nature (e.g., flammable, hazardous).
   3. Follow the First-In, First-Out (FIFO) principle to ensure that older stock is used before newer stock.
   4. Ensure that storage areas are clearly labelled and materials are stored off the floor on pallets or shelves.
   5. Maintain proper environmental conditions (e.g., temperature, humidity) for the storage of each type of material as per its specifications.
3. Labelling of Materials
   1. Ensure that all materials are clearly labelled with the following information:
      • Material name and code
      • Batch or lot number
      • Quantity
      • Storage conditions
      • Expiration date, if applicable
      • Status (e.g., quarantined, released, rejected)
   2. Check labels for legibility and accuracy regularly.
   3. Replace any damaged or illegible labels immediately.
4. Handling of Rejected or Expired Materials
   1. Segregate rejected or expired materials from other stock and label them accordingly.
   2. Store rejected or expired materials in a designated area to prevent accidental use.
   3. Follow the appropriate disposal procedures for rejected or expired materials as per regulatory and company guidelines.
5. Inventory Management
   1. Conduct regular inventory audits to ensure accuracy and compliance with this SOP.
   2. Update the inventory management system with any changes in material status, quantity, or location.
   3. Investigate and resolve any discrepancies found during inventory audits promptly.
6. Training
   1. Ensure that all personnel involved in material handling and storage are trained and competent in the procedures outlined in this SOP.
   2. Maintain training records for all personnel involved in material handling and storage activities.

6) Abbreviations, if any

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• FIFO: First-In, First-Out

7) Documents, if any

• Inventory Management System Records
• Material Receipt Log
• Inspection Records
• Disposal Records

8) Reference, if any

• Current Good Manufacturing Practice (cGMP) guidelines
• Company-specific material handling and storage guidelines

9) SOP Version

Version 1.0