Standard Operating Procedure for Personnel Hygiene Practices in Ointment Formulation

1) Purpose

The purpose of this SOP is to establish hygiene practices for personnel involved in the ointment formulation process to prevent contamination and ensure product quality and safety.

2) Scope

This SOP applies to all personnel working in the ointment formulation area, including production, quality control, and maintenance staff.

3) Responsibilities

– All Personnel: Responsible for adhering to hygiene practices outlined in this SOP.
– Quality Assurance (QA): Responsible for monitoring compliance with hygiene practices and providing necessary training.
– Supervisors: Responsible for ensuring their teams follow hygiene practices.

4) Procedure

1. Personal Hygiene:
1.1 Hand Hygiene:
1.1.1 Wash hands thoroughly with soap and water before entering production areas.
1.1.2 Use alcohol-based hand sanitizers where appropriate.
1.2 Grooming:
1.2.1 Keep nails trimmed and clean.
1.2.2 Avoid wearing cosmetics or strong fragrances in production areas.

Protective Clothing:
2.1 Garbing:
2.1.1 Wear clean, appropriate protective clothing (e.g., lab coats, gloves, hairnets) before entering production areas.
2.1.2 Change protective clothing regularly and when moving between different production areas.

2.2 Footwear:
2.2.1 Wear designated footwear or shoe covers in production areas.
2.2.2 Ensure footwear is clean and in good condition.

Health and Illness:
3.1 Health Monitoring:
3.1.1 Report any symptoms of illness (e.g., fever, cough, gastrointestinal issues) to a supervisor immediately.
3.1.2 Refrain from working in production areas if experiencing symptoms of illness.

3.2 Injury Reporting:
3.2.1 Report any injuries sustained in the production area to a supervisor.
3.2.2 Follow first aid and medical treatment protocols as necessary.

Hygiene Training:
4.1 Training Programs:
4.1.1 Participate in regular hygiene training sessions provided by QA.
4.1.2 Stay updated on any changes to hygiene practices and SOPs.

4.2 Documentation:
4.2.1 Document all hygiene training sessions and maintain training records.
4.2.2 Review and update training materials periodically.

5) Abbreviations, if any

– QA: Quality Assurance
– SOP: Standard Operating Procedure

6) Documents, if any

– Hygiene Training Records
– Incident and Illness Reports

7) Reference, if any

– FDA Guidance for Industry: Sanitary Transportation of Human and Animal Food
– WHO Guide to Good Manufacturing Practice (GMP) Requirements

8) SOP Version

Version 1.0