Standard Operating Procedure for Reviewing Cleaning Records for Equipment and Facilities
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/229/2025 |
| Supersedes | SOP/TAB/229/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 01/04/2026 |
| Effective Date | 06/04/2026 |
| Review Date | 01/04/2027 |
1. Purpose
The purpose of this SOP is to outline the process for reviewing cleaning records for equipment and facilities used in tablet manufacturing. It ensures that all cleaning activities are documented, performed correctly, and comply with GMP guidelines to prevent cross-contamination and ensure product safety.
2. Scope
This SOP applies to all equipment and facilities used in the manufacturing, processing, and packaging of tablets. It covers the review of cleaning records for areas such as production equipment, storage areas, and packaging lines.
3. Responsibilities
- QA Manager: Responsible for overseeing the review of cleaning records to ensure compliance with GMP standards.
- Cleaning Personnel: Responsible for executing cleaning procedures in accordance with established protocols.
- Operations Team: Ensures that cleaning records are completed and maintained in accordance with SOPs.
- Regulatory Affairs Team: Ensures that cleaning records meet regulatory requirements and assist in audits when necessary.
4. Accountability
The QA Manager is accountable for ensuring that all cleaning records are reviewed and compliant with internal policies and external regulatory standards. The Operations Team is responsible for the proper completion of cleaning records and ensuring that all cleaning activities are carried out as per the cleaning protocols.
5. Procedure
5.1 Cleaning Schedule
- Establish a cleaning schedule for equipment and facilities based on the frequency of use and regulatory requirements (Annexure-1).
- Ensure that the cleaning schedule is reviewed and updated regularly, especially when new equipment or facilities are introduced (Annexure-2).
- Ensure that the cleaning schedule includes details such as cleaning agents, cleaning methods, and verification procedures (Annexure-3).
5.2 Cleaning Record Documentation
- Each cleaning activity must be documented on a cleaning record form, which includes information such as the equipment or area cleaned, the cleaning agent used, the date of cleaning, and the personnel responsible (Annexure-4).
- Ensure that the cleaning record is signed off by the responsible personnel, including QA review (Annexure-5).
- Maintain cleaning records for a defined retention period in accordance with regulatory requirements (Annexure-6).
5.3 Review of Cleaning Records
- Review cleaning records for completeness, accuracy, and compliance with the cleaning procedure (Annexure-7).
- Ensure that any discrepancies or missing information are addressed and corrected before final approval (Annexure-8).
- Verify that any deviations or corrective actions related to cleaning are documented and resolved (Annexure-9).
5.4 Validation of Cleaning Procedures
- Ensure that all cleaning procedures are validated to confirm they effectively remove residue and prevent cross-contamination (Annexure-10).
- Review cleaning validation reports to ensure that they meet acceptance criteria and comply with GMP guidelines (Annexure-11).
5.5 Corrective Actions
- If cleaning records show discrepancies or deviations, initiate corrective actions as per the established CAPA (Corrective and Preventive Action) process (Annexure-12).
- Ensure that the root cause of any cleaning issues is identified and documented (Annexure-13).
- Follow up to ensure that corrective actions are implemented and the issue does not recur.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- CAPA: Corrective and Preventive Action
- GMP: Good Manufacturing Practice
- FDA: Food and Drug Administration
7. Documents
- Cleaning Schedule (Annexure-1)
- Cleaning Record (Annexure-2)
- Cleaning Procedure (Annexure-3)
- Cleaning Record Documentation (Annexure-4)
- Cleaning Record Review Form (Annexure-5)
- Cleaning Record Retention Log (Annexure-6)
- Cleaning Record Review Checklist (Annexure-7)
- Cleaning Record Deviation Log (Annexure-8)
- Cleaning Validation Report (Annexure-9)
- Cleaning Validation Protocol (Annexure-10)
- Cleaning Validation Report Review Log (Annexure-11)
- Corrective Actions and CAPA Reports (Annexure-12)
- Root Cause Analysis Report (Annexure-13)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (FDA)
- ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
- USP <1079> – Good Storage and Distribution Practices
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 Schedule
| Equipment | Cleaning Frequency | Last Cleaning Date | Next Cleaning Date |
|---|---|---|---|
| Blender | Every batch | 01/04/2026 | 02/04/2026 |
Annexure-2: Cleaning Record Form
| Equipment | Date of Cleaning | Cleaning Agent Used | Responsible Person | QA Review |
|---|---|---|---|---|
| Blender | 01/04/2026 | IPA Solution | John Doe | Approved |
Annexure-3: Cleaning Procedure
| Step | Action | Time/Duration |
|---|---|---|
| 1 | Remove residue from equipment | 10 minutes |
| 2 | Apply cleaning solution | 15 minutes |
Annexure-4: Cleaning Record Documentation
| Equipment | Cleaning Procedure | Completion Date |
|---|---|---|
| Blender | Standard Cleaning | 01/04/2026 |
Annexure-5: Cleaning Record Review Form
| Reviewed By | Review Date | Comments | Approval Status |
|---|---|---|---|
| Jane Smith | 02/04/2026 | No issues found | Approved |
Annexure-6: Cleaning Record Retention Log
| Record Name | Retention Period | Location |
|---|---|---|
| Blender Cleaning Log | 5 years | QA Archive |
Annexure-7: Cleaning Record Review Checklist
| Item | Status |
|---|---|
| Equipment cleaned as per schedule | ✔ |
| Correct cleaning agents used | ✔ |
| Documentation completed | ✔ |
Annexure-8: Cleaning Record Deviation Log
| Deviation | Corrective Action | Resolution Date |
|---|---|---|
| Late cleaning | Re-clean and update records | 02/04/2026 |
Annexure-9: Cleaning Validation Report
| Test Method | Acceptance Criteria | Results |
|---|---|---|
| Residual Solvent Test | Less than 1 ppm | Pass |
Annexure-10: Cleaning Validation Protocol
| Step | Action | Acceptance Criteria |
|---|---|---|
| Step 1 | Validate equipment cleanliness after cleaning | No residual contaminants |
Annexure-11: Cleaning Validation Report Review Log
| Reviewer | Review Date | Comments | Approval Status |
|---|---|---|---|
| John Doe | 03/04/2026 | Validated with no issues | Approved |
Annexure-12: Corrective Actions and CAPA Reports
| Issue Identified | Corrective Action | Due Date | Responsible Person |
|---|---|---|---|
| Cleaning discrepancy | Re-clean and retrain personnel | 10/04/2026 | Jane Smith |
Annexure-13: Root Cause Analysis Report
| Root Cause | Analysis Method | Action Taken |
|---|---|---|
| Lack of adherence to cleaning schedule | 5 Whys Analysis | Revised cleaning schedule and retrained personnel |
Annexure-14: Cleaning SOPs and References
| Reference SOP | Version | Approval Date |
|---|---|---|
| Cleaning of Equipment SOP | V 2.0 | 01/03/2026 |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP creation | New process | QA Head |
| 01/02/2025 | 2.0 | Revised cleaning schedules and documentation processes | Process optimization | QA Head |