Standard Operating Procedure for Personal Hygiene and GMP Compliance
1) Purpose
This SOP describes the personal hygiene practices required to comply with Good Manufacturing Practices (GMP) in a pharmaceutical production environment. Proper hygiene minimizes the risk of contamination during production.
2) Scope
This SOP applies to all personnel working in GMP-regulated production areas at [Company Name].
3) Responsibilities
- All Employees: Responsible for following personal hygiene guidelines, including washing hands, wearing clean uniforms, and reporting any health issues.
- Supervisors: Responsible for ensuring that employees adhere to GMP hygiene requirements and reporting any deviations to Quality Assurance (QA).
4) Procedure
4.1 Personal Hygiene Requirements
4.1.1 Hand Washing
- All employees must wash their hands thoroughly with soap and water before entering production areas, after using the restroom, and after handling any materials that could lead to contamination.
- Hand sanitizers must be used in addition to hand washing where required, particularly before handling sterile or high-risk materials.
4.1.2 Clean Clothing and Protective Gear
- All employees must wear clean uniforms or lab coats and GMP-compliant protective gear, including gloves, hairnets, beard covers (if applicable), and safety glasses. Protective
gear must be worn at all times in GMP-regulated areas.
Protective gear must be changed regularly, especially if visibly soiled or damaged.
4.2 Restrictions for GMP Areas
4.2.1 Prohibited Activities
- Eating, drinking, smoking, and chewing gum or tobacco are strictly prohibited in GMP-regulated production areas. These activities must be conducted in designated break areas only.
- Wearing jewelry (e.g., rings, bracelets, watches) is not permitted in cleanrooms or other sensitive areas, as these items may harbor contaminants.
4.2.2 Health Restrictions
- Employees suffering from any illness, particularly infectious diseases, must report to their supervisor before entering GMP areas. Supervisors must evaluate whether the employee should be excluded from production activities to prevent contamination risks.
4.3 Post-Operation Activities
4.3.1 Reporting Deviations
- If any deviation from hygiene standards is observed (e.g., improper protective gear, unreported illness), employees must report the issue to their supervisor immediately.
- Supervisors must document all hygiene-related deviations in the deviation log and report them to Quality Assurance (QA).
4.3.2 Training and Monitoring
- All personnel must undergo regular GMP and personal hygiene training sessions. QA will conduct periodic inspections to ensure compliance with hygiene and GMP standards.
- Document all training sessions in the employee training log and maintain records for QA review.
5) Abbreviations, if any
- GMP: Good Manufacturing Practices
- QA: Quality Assurance
6) Documents, if any
- Deviation Log
- Employee Training Log
7) References, if any
- GMP guidelines as per FDA or EU regulations
- Internal SOP for GMP compliance
8) SOP Version
Version 1.0
Annexure
1. Deviation Log Template
| Date | Employee ID | Deviation Description | Supervisor Initials | QA Approval |
|---|---|---|---|---|
| DD/MM/YYYY | Employee ID | Details of the deviation | Supervisor Name | QA Name |