Standard Operating Procedure for Health and Hygiene Standards

1) Purpose

The purpose of this SOP is to define the health and hygiene requirements to ensure a clean and safe working environment in compliance with regulatory standards and to prevent contamination during manufacturing processes.

2) Scope

This SOP applies to all employees, contractors, and visitors in the manufacturing areas of the facility.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 All Personnel:

Responsible for adhering to health and hygiene requirements and reporting any health issues.

3.2 Department Managers:

Responsible for ensuring their teams comply with health and hygiene standards.

3.3 Quality Assurance (QA) Manager:

Responsible for monitoring hygiene practices and conducting regular inspections.

4) Procedure

4.1 Personal Hygiene:

4.1.1 Employees must maintain personal cleanliness, including regular hand washing and use of sanitizers.
4.1.2 Employees must wear clean, appropriate clothing and personal protective equipment (PPE) as required.
4.1.3 Food, drinks, and tobacco products are prohibited in manufacturing and storage areas.

4.2 Health Requirements:

4.2.1 Employees must report any illness or symptoms that could affect product safety.
4.2.2 Medical examinations may be required to ensure fitness for duty in certain roles.
4.2.3 Sick employees must follow company policies for sick leave and return to work.

4.3 Facility Hygiene:

4.3.1 Regular cleaning schedules must be established and followed for all manufacturing areas.
4.3.2 Use appropriate cleaning agents and disinfectants approved for use in pharmaceutical environments.
4.3.3 Maintain proper waste disposal practices to prevent contamination.

4.4 Monitoring and Auditing:

4.4.1 Conduct regular hygiene audits and inspections of manufacturing areas.
4.4.2 Document findings and corrective actions taken to address any issues.
4.4.3 Review and update hygiene procedures as necessary to ensure ongoing compliance.

5) Abbreviations, if any

PPE – Personal Protective Equipment
QA – Quality Assurance

6) Documents, if any

1. Personal Hygiene Checklist
2. Cleaning Schedule Logs
3. Health Declaration Forms
4. Hygiene Audit Reports

7) Reference, if any

1. FDA Guidance on Sanitation and Hygiene
2. WHO Guidelines on Hygiene and Health in Pharmaceutical Manufacturing

8) SOP Version

Version 1.0