Standard Operating Procedure for Cleaning and Sanitization of Manufacturing Areas
1) Purpose
This SOP outlines the procedures for cleaning and sanitizing manufacturing areas to prevent contamination and ensure compliance with GMP (Good Manufacturing Practices) standards. Clean environments are essential for the production of safe and effective pharmaceutical products.
2) Scope
This SOP applies to all personnel involved in the cleaning and sanitization of manufacturing areas at [Company Name].
3) Responsibilities
- Operators: Responsible for performing daily, weekly, and monthly cleaning tasks and documenting them accordingly.
- Supervisors: Ensure that cleaning tasks are performed according to the schedule and verify that the area is clean before production begins.
- Quality Assurance (QA): Conducts regular inspections to ensure cleaning practices meet GMP requirements.
4) Procedure
4.1 Cleaning and Sanitization Schedule
4.1.1 Daily Cleaning Tasks
- At the end of each production shift, clean all equipment surfaces, countertops, and floors with an approved cleaning solution. Wipe down frequently touched surfaces such as door handles and switches.
- Sanitize the area with an appropriate disinfectant once cleaning is complete. Document all activities in the cleaning log.
4.1.2 Weekly Deep Cleaning
- Perform a
deep cleaning of all equipment, floors, and walls in the manufacturing area. Remove any removable parts from machinery and clean them separately using an approved cleaning solution.
Use a stronger disinfectant solution for sanitization, focusing on areas prone to contamination. Record all cleaning and sanitization tasks in the cleaning log and submit for QA review.
4.1.3 Monthly Sterilization
- Perform a complete sterilization of the manufacturing area once per month. Use approved sterilization agents and techniques, including UV light or fogging methods, to achieve sterile conditions in the entire facility.
- Document the sterilization process in the cleaning log and submit for QA approval before starting the next production cycle.
4.2 Cleaning Equipment and Materials
4.2.1 Approved Cleaning Solutions
- Use only GMP-approved cleaning solutions and disinfectants, as listed in the company’s approved cleaning materials log. Do not mix chemicals unless specified in the cleaning guidelines.
- Ensure that all cleaning solutions are properly labeled and stored in designated areas. Replace any expired cleaning materials immediately.
4.2.2 Cleaning Tools
- Use designated cleaning tools such as mops, brooms, and wipes for specific areas (e.g., floors, walls, countertops) to avoid cross-contamination. Clean and disinfect these tools after each use.
- Document the cleaning of tools in the cleaning tools log.
4.3 Post-Operation Activities
4.3.1 Documentation
- Record all cleaning and sanitization tasks in the cleaning log. Ensure that all cleaning agents used are documented, along with the areas cleaned, the date and time, and the initials of the operator performing the task.
- Submit the cleaning log to QA for review at the end of each shift.
4.3.2 QA Inspections
- Quality Assurance (QA) personnel will perform routine inspections to verify that all cleaning and sanitization procedures are being followed correctly. Any deviations must be documented in the deviation log.
- QA must approve the cleaning log before production can resume in the cleaned area.
5) Abbreviations, if any
- GMP: Good Manufacturing Practices
- QA: Quality Assurance
6) Documents, if any
- Cleaning Log
- Cleaning Tools Log
- Deviation Log
7) References, if any
- Internal SOP for cleaning agents and materials
- Manufacturer’s manual for sterilization equipment
8) SOP Version
Version 1.0
Annexure
1. Cleaning Log Template
| Date | Area Cleaned | Cleaning Solution Used | Sanitization Method | Operator Initials | QA Approval |
|---|---|---|---|---|---|
| DD/MM/YYYY | Room or Equipment Name | Cleaning Solution | Disinfectant/Sterilization Method | Operator Name | QA Name |