Cleaning and Sanitation Procedures

1) Purpose

The purpose of this SOP is to establish standardized procedures for cleaning and sanitizing equipment and facilities to ensure a hygienic manufacturing environment and prevent contamination.

2) Scope

This SOP applies to all equipment and facilities within the pharmaceutical manufacturing facility that require regular cleaning and sanitation.

3) Responsibilities

– Production personnel are responsible for executing cleaning and sanitation procedures.
– QA personnel are responsible for monitoring the effectiveness of cleaning and sanitation activities.
– Maintenance personnel are responsible for ensuring that cleaning equipment and supplies are available and in good condition.

4) Procedure

1. Cleaning Schedule
1.1. Develop a cleaning schedule for all equipment and facilities, specifying the frequency and type of cleaning required.
1.2. Ensure the schedule is visible and accessible to all relevant personnel.
2. Cleaning Procedures for Equipment
2.1. Dismantle equipment as necessary to access all parts for cleaning.
2.2. Use approved cleaning agents and methods specific to each type of equipment.
2.3. Scrub and rinse equipment thoroughly to remove residues.
2.4. Inspect equipment after cleaning to ensure all residues are removed.
2.5. Reassemble equipment and document the cleaning activity in the equipment log.
3. Cleaning Procedures for Facilities
3.1. Clean floors, walls, and ceilings using appropriate cleaning agents and methods.
3.2. Focus on high-touch areas such as door handles, switches, and benches.
3.3. Dispose of waste materials in designated containers.
3.4. Document facility cleaning activities in the cleaning log.
4. Sanitation Procedures
4.1. Sanitize cleaned equipment and facilities using approved sanitizing agents.
4.2. Follow the manufacturer’s instructions for the concentration and contact time of sanitizing agents.
4.3. Ensure all surfaces are thoroughly wetted with the sanitizing solution.
4.4. Allow sanitized areas to air dry before use.
5. Verification and Monitoring
5.1. Conduct regular inspections to verify the cleanliness and sanitation of equipment and facilities.
5.2. Use microbiological swabs and tests to monitor the effectiveness of cleaning and sanitation procedures.
5.3. Document the results of inspections and tests in the monitoring log.
6. Handling Cleaning Supplies
6.1. Store cleaning agents and supplies in designated areas, away from production materials.
6.2. Label all cleaning agents with their contents and expiration dates.
6.3. Ensure cleaning equipment is cleaned and maintained after each use.
7. Training
7.1. Train all relevant personnel on proper cleaning and sanitation procedures.
7.2. Provide regular refresher training and updates on new cleaning protocols.
7.3. Document all training activities in the training log.
8. Documentation
8.1. Maintain detailed records of all cleaning and sanitation activities, including dates, times, personnel involved, and results of inspections.
8.2. Ensure all records are reviewed and approved by QA personnel.

5) Abbreviations, if any

– QA: Quality Assurance
– SOP: Standard Operating Procedure

6) Documents, if any

– Cleaning Schedule
– Equipment Cleaning Log
– Facility Cleaning Log
– Sanitation Monitoring Log
– Training Log

7) Reference, if any

– FDA 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
– WHO Good Manufacturing Practices for Pharmaceutical Products

8) SOP Version

Version 1.0