Purpose

Scope

This SOP applies to all storage areas within the pharmaceutical facility where pharmaceutical products are stored, including warehouses, cold rooms, and controlled storage areas.

Responsibilities

• Warehouse Manager: Responsible for overall implementation and compliance with storage SOP.
• Quality Assurance (QA) Department: Responsible for periodic inspections to ensure compliance with storage conditions.
• Warehouse Staff: Responsible for adhering to storage guidelines and reporting any deviations or issues.

Procedure

1. Temperature Control: Maintain temperature within specified ranges as per product requirements. Monitor temperature regularly using calibrated thermometers.
2. Humidity Control: Maintain humidity levels within acceptable limits to prevent moisture-related damage to products. Use dehumidifiers if necessary.
3. Storage Organization: Store pharmaceutical products according to their storage requirements, including segregation of different temperature-sensitive products.
4. Security Measures: Implement security measures such as access controls, CCTV surveillance, and restricted access to authorized personnel only.
5. Documentation: Maintain accurate records of temperature and humidity logs, including any deviations or corrective actions taken.
6. Cleaning and Maintenance: Regularly clean and maintain storage equipment and facilities to prevent contamination and ensure proper functioning.
7. Emergency Preparedness: Develop and implement procedures for addressing emergencies such as power outages, equipment failures, or environmental hazards.
8. Training: Provide training to warehouse staff on storage SOPs, including proper handling and storage practices.

Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• CCTV: Closed-Circuit Television

Documents

• Temperature and humidity logs
• Training records
• Emergency procedures manual

Reference

Pharmaceutical Storage and Distribution Guidelines (if applicable)