Standard Operating Procedure for Material Handling

Purpose

The purpose of this SOP is to establish procedures for the proper handling, storage, and transportation of materials within the pharmaceutical facility, ensuring the integrity, safety, and traceability of materials throughout the supply chain.

Scope

This SOP applies to all personnel involved in material handling, including warehouse staff, operators, and quality control personnel.

Responsibilities

• Warehouse Staff: Responsible for receiving, storing, and issuing materials in accordance with this SOP.
• Operators: Responsible for transporting materials within the manufacturing area following established procedures.
• Quality Control Personnel: Responsible for verifying the integrity and compliance of materials received and used in production.

Procedure

1. Receive materials in a designated receiving area, checking the accompanying documentation against the purchase order for accuracy.
2. Inspect materials for any visible damage, contamination, or discrepancies in quantity.
3. Label materials with unique identification numbers and store them in the designated storage areas according to their specifications (temperature, humidity, etc.).
4. Regularly monitor and record environmental conditions in storage areas to ensure compliance with material requirements.
5. Issue materials to production areas based on approved requisitions, ensuring proper documentation and traceability.
6. Transport materials within the manufacturing area using appropriate equipment, following designated pathways and avoiding cross-contamination.
7. Use proper handling techniques to prevent damage or contamination of materials during transportation.
8. Ensure that materials used in production are within their expiration dates and meet specified quality standards.
9. Dispose of expired or damaged materials according to established procedures and environmental regulations.
10. Regularly review and update the inventory system to maintain accurate records of material quantities and locations.
11. Train personnel involved in material handling on proper procedures, equipment usage, and safety precautions.
12. Implement corrective actions for any deviations or non-conformances identified during material handling processes.
13. Maintain a clean and organized workspace to facilitate efficient material handling and prevent safety hazards.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Material Requisition Forms
• Material Inventory Records
• Material Disposal Logs
• Training Records

Reference

Good Manufacturing Practice (GMP) Regulations

SOP Version

Version 1.0