Standard Operating Procedure for Cleaning and Sanitization of Storage Facilities

Purpose

The purpose of this SOP is to establish procedures for the cleaning and sanitization of storage facilities within the pharmaceutical distribution facility, ensuring compliance with regulatory requirements and Good Distribution Practice (GDP) guidelines to maintain product integrity and safety.

Scope

This SOP applies to all personnel involved in cleaning and sanitization activities within storage facilities, including warehouse staff, janitorial personnel, and contractors.

Responsibilities

• The Facilities Management Team is responsible for coordinating and overseeing cleaning and sanitization activities within storage facilities.
• The Warehouse Supervisor is responsible for ensuring that cleaning schedules are followed and that cleaning tasks are performed effectively.
• All personnel are responsible for adhering to cleaning and sanitization procedures and reporting any issues or concerns to the Facilities Management Team.

Procedure

1. Preparation for Cleaning:
   • Clear storage areas of products, materials, and equipment to facilitate thorough cleaning.
   • Ensure that cleaning personnel have access to appropriate cleaning supplies, equipment, and personal protective equipment (PPE).
2. Cleaning Process:
   • Remove debris, dust, and other visible contaminants from storage surfaces using dry cleaning methods, such as sweeping or vacuuming.
   • Apply suitable cleaning agents or disinfectants to surfaces using approved methods, such as spraying, mopping, or wiping.
   • Focus on high-touch surfaces, shelving, floors, walls, and other areas prone to contamination.
3. Rinsing and Drying:
   • Rinse cleaned surfaces thoroughly with clean water to remove any residue from cleaning agents or disinfectants.
   • Allow surfaces to air dry completely before reintroducing products or materials into the storage area.
4. Verification and Inspection:
   • Inspect cleaned areas to ensure that all surfaces are visibly clean and free from contamination.
   • Verify the effectiveness of cleaning and sanitization procedures through environmental monitoring, if applicable.
5. Documentation:
   • Maintain detailed records of cleaning activities, including cleaning schedules, cleaning agents used, and inspection results.
   • Document any deviations or issues encountered during the cleaning process and the actions taken to address them.
6. Review and Continuous Improvement:
   • Review cleaning and sanitization procedures regularly to ensure effectiveness and compliance with regulatory requirements.
   • Implement any necessary improvements or corrective actions identified through audits, inspections, or feedback.

Abbreviations

• GDP – Good Distribution Practice
• PPE – Personal Protective Equipment

Documents

Reference documents related to cleaning and sanitization may include:

• Cleaning schedules
• Cleaning agent specifications
• Cleaning validation reports
• Inspection records
• Corrective action reports

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0