Standard Operating Procedure for Personal Hygiene for Manufacturing Staff

1) Purpose

The purpose of this SOP is to define the personal hygiene requirements for manufacturing staff to prevent contamination and ensure a hygienic environment for the production of injection products.

2) Scope

This SOP applies to all manufacturing staff at [Company Name] involved in the production of intramuscular, subcutaneous, and intravenous injection products.

3) Responsibilities

The responsibilities of this SOP include:
– Manufacturing Staff: Adhering to personal hygiene requirements.
– Supervisors: Monitoring staff compliance with personal hygiene practices.
– Quality Assurance (QA) Department: Conducting periodic audits and providing training on personal hygiene practices.

4) Procedure

4.1 Personal Hygiene Requirements
4.1.1 Staff must wash their hands thoroughly with soap and water before entering the manufacturing area and after any activity that could cause contamination (e.g., eating, using the restroom).
4.1.2 Nails should be kept short and clean; nail polish and artificial nails are prohibited.
4.1.3 Jewelry, including rings, watches, and earrings, should not be worn in the manufacturing area.
4.2 Clothing and Protective Gear
4.2.1 Staff must wear clean, company-issued uniforms and appropriate protective gear (e.g., gloves, masks, hairnets) as specified for their role.
4.2.2 Uniforms and protective gear should be changed regularly and immediately if they become contaminated.
4.3 Health and Hygiene
4.3.1 Staff should report any illness or open wounds to their supervisor before starting work.
4.3.2 Anyone with symptoms of illness (e.g., fever, cough, gastrointestinal issues) should not enter the manufacturing area until cleared by medical personnel.
4.4 Training
4.4.1 The QA Department should provide regular training sessions on personal hygiene practices and their importance in preventing contamination.
4.4.2 Training records should be maintained for each staff member.
4.5 Monitoring and Compliance
4.5.1 Supervisors should conduct daily checks to ensure compliance with personal hygiene practices.
4.5.2 The QA Department should perform periodic audits and report any non-compliance issues, followed by corrective actions.
4.6 Documentation
4.6.1 Maintain records of training sessions, daily compliance checks, and periodic audits.
4.6.2 Ensure all records are signed and dated by the responsible personnel.

5) Abbreviations, if any

– QA: Quality Assurance

6) Documents, if any

– Training Records
– Daily Hygiene Compliance Checklists
– Audit Reports

7) Reference, if any

– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards

8) SOP Version

Version 1.0