Standard Operating Procedure for Approving Equipment Cleaning Procedures
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/208/2025 |
| Supersedes | SOP/TAB/208/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
The purpose of this SOP is to outline the procedure for approving equipment cleaning procedures within the tablet manufacturing department. It ensures that cleaning procedures are validated and meet GMP standards to prevent cross-contamination and ensure product quality.
2. Scope
This SOP applies to all equipment cleaning procedures in the tablet manufacturing area, including cleaning methods for tablet presses, coating machines, granulation equipment, and any other equipment used in production.
3. Responsibilities
- Quality Assurance (QA) Manager: Responsible for ensuring the review and approval of cleaning procedures and validation of equipment cleaning.
- Cleaning Validation Team: Responsible for preparing cleaning procedures, performing validation, and ensuring compliance with the SOP.
- Production Team: Responsible for following the approved cleaning procedures during regular operations and documenting cleaning activities.
- Regulatory Affairs: Ensures compliance with regulatory guidelines such as GMP and FDA requirements for equipment cleaning.
4. Accountability
The QA Manager is accountable for ensuring the cleaning procedures are reviewed, approved, and validated. The Cleaning Validation Team and Production Team are responsible for executing cleaning procedures and ensuring proper documentation.
5. Procedure
5.1 Development of Equipment Cleaning Procedures
- Develop cleaning procedures for all manufacturing equipment, including tablet presses, coating machines, and granulation equipment.
- The cleaning procedure should define the cleaning agents, cleaning methods, and frequency of cleaning based on the type of equipment and the product manufactured.
- Ensure that the cleaning procedure specifies acceptable limits for residues, microbial contamination, and cleaning agent residues.
- The procedure must be reviewed and approved by the Cleaning Validation Team before being submitted for final QA approval (Annexure-1).
5.2 Review of Cleaning Procedures
- QA must review the cleaning procedure to ensure compliance with GMP and internal standards, ensuring the procedure is suitable for the intended use and meets all regulatory requirements.
- QA should check the following during the review:
- Whether the cleaning methods are effective for the type of equipment and product.
- Whether the cleaning agents and concentrations are appropriate for the intended purpose.
- Whether the procedure includes the necessary verification steps such as swab sampling or rinse testing for residues.
- Ensure that all critical steps in the cleaning process are well documented and include relevant acceptance criteria.
5.3 Approval of Equipment Cleaning Procedures
- Once the cleaning procedure has been reviewed and deemed compliant, QA will approve the procedure for implementation (Annexure-2).
- Ensure that the cleaning procedure is signed off by the QA Manager, and approval is documented for record-keeping.
- The approved cleaning procedure will be implemented in the manufacturing area by the Production Team.
5.4 Validation of Cleaning Procedures
- The cleaning procedure must be validated to ensure that the procedure effectively removes residues and contaminants.
- Validation must include tests such as swab sampling or rinse sampling for residues, as well as microbial testing to ensure cleanliness (Annexure-3).
- The validation study should be conducted under normal operating conditions, and the results must meet predefined acceptance criteria for residue levels and cleanliness.
- Ensure that the validation process includes multiple runs to demonstrate consistency and effectiveness over time.
5.5 Documentation of Cleaning Procedure Results
- Once the cleaning procedure has been validated, document the results, including test results and any deviations from the procedure.
- The results should be compiled into a Cleaning Validation Report, which is reviewed and approved by the QA team (Annexure-4).
- All results should be stored in a secure location for future reference, audits, and inspections.
5.6 Re-Validation of Cleaning Procedures
- Revalidate the cleaning procedure when there are significant changes in the manufacturing process, product formulations, or cleaning agents.
- If the procedure fails re-validation or if contamination risks are identified, initiate corrective actions and adjust the cleaning procedure accordingly.
- Ensure that all re-validation results are documented and approved in the same manner as the original validation.
5.7 Documentation and Record Keeping
- Ensure that all cleaning procedure documents, including the cleaning procedure itself, validation results, and approval records, are properly archived and easily accessible for future audits and regulatory inspections.
- Maintain records for a minimum of 5 years or as required by regulatory guidelines.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
- CAPA: Corrective and Preventive Action
- IPQC: In-Process Quality Control
- FDA: Food and Drug Administration
7. Documents
- Equipment Cleaning Procedure (Annexure-1)
- Cleaning Validation Report (Annexure-2)
- Cleaning Procedure Validation Results (Annexure-3)
- Final Validation Report (Annexure-4)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ISO 9001 – Quality Management Systems
- GMP Guidelines for Pharmaceutical Industry
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Equipment Cleaning Procedure
| Equipment | Cleaning Agent | Procedure | Frequency |
|---|---|---|---|
| Tablet Press | Detergent A | Manual Cleaning | After every batch |
Annexure-2: Cleaning Validation Report
| Batch Number | Cleaning Method | Test Results | Conclusion |
|---|---|---|---|
| Batch-12345 | Manual Cleaning | Pass | Clean |
Annexure-3: Cleaning Procedure Validation Results
| Validation Test | Result | Acceptance Criteria | Pass/Fail |
|---|---|---|---|
| Swab Sampling | Residue 5 ppm | Less than 10 ppm | Pass |
Annexure-4: Final Validation Report
| Validation Batch | Tested By | Validation Status | Approval Date |
|---|---|---|---|
| Batch-12345 | Jane Smith | Approved | 01/04/2026 |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/02/2025 | 2.0 | Updated cleaning methods and validation process | Revised cleaning protocols | QA Head |