Procedure for Documentation of Cleaning Processes
| Department | Quality Assurance (QA)/Production/Engineering |
|---|---|
| SOP No. | SOP/Ointment/060 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for documenting cleaning activities in the pharmaceutical manufacturing facility. Proper documentation ensures compliance with Good Manufacturing Practices (GMP), maintains traceability, and verifies cleaning effectiveness.
2. Scope
This SOP applies to all personnel involved in cleaning and documenting the cleaning processes for equipment, utensils, and facilities in the manufacturing and production areas.
3. Responsibilities
- Cleaning Personnel: Conducts cleaning as per approved SOPs and records details in logbooks.
- Production Supervisor: Verifies cleaning records and ensures compliance.
- Quality Assurance (QA) Personnel: Reviews and approves cleaning documentation.
- Engineering Team: Ensures equipment cleaning validation and maintenance records are updated.
4. Accountability
The QA and Production Managers are accountable for ensuring that cleaning documentation is maintained as per regulatory requirements.
5. Procedure
5.1 Types of Cleaning Documentation
- Cleaning Log: Records daily cleaning activities of equipment and facility areas.
- Cleaning Validation Report: Documents validation of cleaning procedures.
- Equipment Cleaning Record: Maintains cleaning history for each piece of equipment.
- Facility Cleaning Checklist: Ensures facility areas are cleaned according to schedule.
5.2 Recording Cleaning Activities
- Use designated logbooks or electronic records for
documenting cleaning activities.
Ensure the following details are recorded for each cleaning event:
Ensure logbooks are maintained in real-time, with no backdated entries.
- Date and time of cleaning
- Equipment/area cleaned
- Cleaning agent used
- Method of cleaning (manual, automated, CIP)
- Person performing cleaning
- Verification signature of supervisor
5.3 Cleaning Verification and Approval
- QA personnel must inspect and verify that cleaning has been completed as per SOPs.
- Swab or rinse samples should be collected for microbial and residue analysis.
- QA must approve cleaning documentation before equipment is reused.
5.4 Handling Deviations and Corrections
- Any missed or incomplete cleaning records must be reported to the QA department.
- Corrections must be made with a single line strike-through, initialed, and dated.
- A deviation report must be raised if cleaning was not performed as per SOP.
5.5 Storage and Retention of Cleaning Records
- Cleaning records must be stored securely and easily accessible for audits.
- Records should be retained for at least 5 years as per GMP requirements.
- Electronic records, if used, must be backed up regularly.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- CIP – Clean-in-Place
7. Documents
- Cleaning Log (Annexure-1)
- Cleaning Validation Report (Annexure-2)
- Equipment Cleaning Record (Annexure-3)
- Facility Cleaning Checklist (Annexure-4)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Cleaning Log
| Date | Equipment/Area | Cleaning Method | Cleaning Agent | Performed By | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | Mixing Tank | Manual | Detergent Solution | Operator | QA Officer |
| 02/02/2025 | Filling Machine | CIP | Peracetic Acid | Operator | QA Officer |
Annexure-2: Cleaning Validation Report
| Date | Equipment | Validation Method | Acceptance Criteria | Result | Approved By |
|---|---|---|---|---|---|
| 01/02/2025 | Mixing Tank | Swab Test | Below 10 ppm residue | Pass | QA Head |
| 02/02/2025 | Filling Machine | Rinse Test | No microbial growth | Pass | QA Head |
Annexure-3: Equipment Cleaning Record
| Date | Equipment ID | Cleaning Agent | Cleaning Frequency | Verified By |
|---|---|---|---|---|
| 01/02/2025 | MT-101 | Detergent | Daily | QA Officer |
| 02/02/2025 | FM-202 | Peracetic Acid | Weekly | QA Officer |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |