Standard Operating Procedure for Cleaning and Sanitizing Manufacturing Areas

1) Purpose

The purpose of this SOP is to establish a procedure for the cleaning and sanitation of manufacturing areas to ensure a contamination-free environment and compliance with GMP standards.

2) Scope

This SOP applies to all manufacturing, storage, and quality control areas within the facility.

3) Responsibilities

The responsibilities for this SOP are divided among various roles:

3.1 Cleaning Staff:

Responsible for performing cleaning and sanitation tasks according to the SOP.

3.2 Department Managers:

Responsible for ensuring their areas are properly cleaned and sanitized.

3.3 Quality Assurance (QA) Manager:

Responsible for verifying the effectiveness of cleaning and sanitation activities.

4) Procedure

4.1 Cleaning Schedule:

4.1.1 Develop a cleaning schedule for all areas, including frequency and specific tasks.
4.1.2 Ensure that the schedule is visible and accessible to all relevant personnel.

4.2 Cleaning Procedures:

4.2.1 Use appropriate cleaning agents and disinfectants approved for use in pharmaceutical environments.
4.2.2 Follow the specified cleaning procedures for each area, including floors, walls, ceilings, and equipment surfaces.
4.2.3 Ensure that cleaning equipment is clean and in good condition before use.
4.2.4 Document all cleaning activities, including date, time, and personnel involved.

4.3 Sanitation Procedures:

4.3.1 Apply disinfectants according to manufacturer instructions and safety guidelines.
4.3.2 Focus on high-touch surfaces and areas prone to contamination.
4.3.3 Allow adequate contact time for disinfectants to be effective.
4.3.4 Rinse surfaces with clean water if required by the disinfectant instructions.

4.4 Monitoring and Verification:

4.4.1 Conduct regular inspections to verify the cleanliness of manufacturing areas.
4.4.2 Perform microbiological testing of surfaces to monitor contamination levels.
4.4.3 Document inspection results and any corrective actions taken.

5) Abbreviations, if any

QA – Quality Assurance
GMP – Good Manufacturing Practices

6) Documents, if any

1. Cleaning Schedule
2. Cleaning Logs
3. Sanitation Records
4. Inspection Reports

7) Reference, if any

1. FDA Guidance on Sanitation and Hygiene
2. WHO Guidelines on Cleaning and Disinfection

8) SOP Version

Version 1.0