Standard Operating Procedure for Personnel Hygiene and Gowning

Purpose

The purpose of this SOP is to establish procedures for maintaining hygiene and gowning standards among personnel working in the pharmaceutical distribution facility, ensuring the prevention of contamination and maintaining product integrity.

Scope

This SOP applies to all personnel, including employees, contractors, and visitors, entering designated areas within the pharmaceutical distribution facility where hygiene and gowning standards are required.

Responsibilities

• The Facility Manager is responsible for implementing and enforcing personnel hygiene and gowning procedures in the distribution facility.
• The Human Resources Manager is responsible for providing training and education on hygiene and gowning requirements to all personnel and ensuring compliance with established procedures.
• All personnel are responsible for adhering to hygiene and gowning protocols outlined in this SOP and maintaining personal cleanliness and proper attire while working in designated areas.

Procedure

1. Hand Hygiene:
   • Wash hands thoroughly with soap and water before entering designated work areas or handling pharmaceutical products, following recommended hand washing techniques and duration.
   • Use alcohol-based hand sanitizers as an alternative hand hygiene method when soap and water are not readily available, ensuring complete coverage and rubbing until hands are dry.
2. Gowning Requirements:
   • Wear appropriate protective clothing, such as gowns, lab coats, or coveralls, when entering cleanroom or controlled areas to prevent contamination of pharmaceutical products.
   • Ensure that gowns are clean, intact, and free from visible soiling or damage before use, and replace them immediately if contaminated or compromised during work activities.
3. Personal Protective Equipment (PPE):
   • Wear additional PPE, such as gloves, hairnets, beard covers, and shoe covers, as required by specific work areas or activities to minimize the risk of product contamination.
   • Inspect PPE for integrity and proper fit before use, ensuring that it covers exposed skin and clothing effectively and is compatible with other protective garments worn.
4. Hygiene Practices:
   • Avoid eating, drinking, smoking, or applying cosmetics in designated work areas to prevent contamination of pharmaceutical products and maintain personal hygiene standards.
   • Cover any cuts, wounds, or skin lesions with waterproof dressings or bandages to prevent microbial contamination and minimize the risk of product contamination.
5. Cleanliness and Orderliness:
   • Maintain cleanliness and orderliness in work areas by disposing of waste materials, cleaning spills promptly, and organizing equipment and supplies to minimize clutter and contamination risks.
   • Regularly clean and sanitize work surfaces, equipment, and shared facilities according to established cleaning schedules and procedures to prevent the accumulation of dirt, dust, or microbial contaminants.

Abbreviations

• SOP – Standard Operating Procedure
• PPE – Personal Protective Equipment

Documents

Reference documents related to personnel hygiene and gowning may include:

• Hygiene and gowning procedures manual
• Training materials on hand hygiene and PPE use
• Cleaning and sanitation schedules
• Regulatory guidelines on personnel hygiene in pharmaceutical facilities

Reference

Good Distribution Practice Guidelines

SOP Version

Version 1.0