Standard Operating Procedure for Personnel Hygiene in Creams Production
1) Purpose
The purpose of this SOP is to establish guidelines and procedures for maintaining high standards of personal hygiene among personnel involved in creams production to prevent contamination and ensure product quality and safety.
2) Scope
This SOP applies to all personnel working in creams production areas, including manufacturing, filling, packaging, and quality control areas.
3) Responsibilities
The Quality Assurance (QA) department is responsible for implementing and monitoring personnel hygiene practices. All personnel working in creams production areas are responsible for adhering to the hygiene guidelines outlined in this SOP.
4) Procedure
4.1 Personal Cleanliness
4.1.1 Ensure that all personnel take a shower and wear clean, appropriate clothing before entering the production area.
4.1.2 Prohibit the use of cosmetics, perfumes, and jewelry in the production areas to avoid contamination.
4.1.3 Maintain short, clean, and unpolished nails.
4.2 Hand Hygiene
4.2.1 Wash hands thoroughly with soap and water before entering production areas, after using the restroom, and after breaks.
4.2.2 Use hand sanitizers provided at entry points and in the production areas to ensure additional hand hygiene.
4.3 Protective Clothing and Equipment
4.3.1 Wear designated uniforms, gowns, hairnets, gloves, masks, and shoe covers while in the production areas.
4.3.2 Change into fresh
4.3.3 Dispose of single-use protective items appropriately and replace them as needed.
4.4 Health and Wellness
4.4.1 Report any illness, skin conditions, or infections to the supervisor or QA immediately.
4.4.2 Exclude personnel with contagious diseases, open wounds, or any condition that may compromise product safety from working in production areas until fully recovered.
4.4.3 Conduct regular health check-ups for personnel to ensure they are fit to work in production areas.
4.5 Training and Compliance
4.5.1 Provide initial and periodic training on personal hygiene practices and their importance in maintaining product quality and safety.
4.5.2 Display hygiene guidelines and reminders prominently in production areas and break rooms.
4.5.3 Monitor personnel adherence to hygiene practices through regular audits and provide feedback and corrective actions as necessary.
5) Abbreviations, if any
QA: Quality Assurance
6) Documents, if any
Health Check-Up Records
Training Records
Hygiene Audit Reports
7) Reference, if any
ICH Q10: Pharmaceutical Quality System
US FDA CFR (Code of Federal Regulations) Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0