Standard Operating Procedure for Personnel Hygiene in Gels Production
1) Purpose
The purpose of this SOP is to establish guidelines and procedures for maintaining hygiene practices among personnel working in the gels production area to prevent contamination and ensure product quality and safety.
2) Scope
This SOP applies to all personnel entering or working within the pharmaceutical manufacturing facility’s gels production department, including employees, contractors, and visitors.
3) Responsibilities
Production Supervisors: Ensure adherence to hygiene practices by personnel.
Quality Assurance (QA) Team: Monitor compliance with hygiene SOPs and conduct audits.
Personnel: Follow hygiene procedures to maintain cleanliness and prevent contamination.
4) Procedure
4.1 Personal Hygiene Practices
4.1.1 Personnel shall maintain personal cleanliness by regular washing of hands and wearing clean uniforms or protective clothing.
4.1.2 Follow proper grooming practices, including keeping hair tied back and avoiding excessive jewelry.
4.2 Protective Clothing and Equipment
4.2.1 Wear appropriate protective clothing, such as gloves, masks, and hair nets, as specified by SOPs.
4.2.2 Replace protective clothing when contaminated or as per schedule to maintain cleanliness.
4.3 Hand Washing and Sanitization
4.3.1 Wash hands thoroughly before entering production areas and after using restroom facilities.
4.3.2 Use approved hand sanitizers or sanitizing solutions as an additional measure for hand hygiene.
4.4 Restricted Activities
4.4.1 Prohibit eating, drinking, smoking, or applying cosmetics in production areas to prevent contamination.
4.4.2 Enforce strict adherence to hygiene practices during breaks and outside designated production areas.
4.5 Hygiene Training and Awareness
4.5.1 Provide initial and ongoing training on hygiene practices and their importance in maintaining product quality.
4.5.2 Conduct periodic refresher training sessions and communicate updates to hygiene procedures as needed.
4.6 Reporting Non-Compliance
4.6.1 Report any observed instances of non-compliance with hygiene procedures to supervisors or QA immediately.
4.6.2 Investigate incidents of non-compliance and implement corrective actions to prevent recurrence.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
– Hygiene SOPs
– Training Records for Personnel Hygiene
– Incident Reports for Non-Compliance
7) Reference, if any
– FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing
– EU GMP Annex 1: Manufacture of Sterile Medicinal Products
– Company-specific hygiene procedures and guidelines
8) SOP Version
Version 1.0