Standard Operating Procedure for Reviewing Cleaning Validation Protocols
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/205/2025 |
| Supersedes | SOP/TAB/205/2022 |
| Page No. | Page 1 of 6 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
To define the procedure for reviewing cleaning validation protocols to ensure that all equipment used in tablet manufacturing is adequately cleaned and meets the required cleaning validation standards. This ensures compliance with regulatory requirements and prevents contamination across production batches.
2. Scope
This SOP applies to all equipment used in tablet manufacturing, including tablet presses, coating machines, granulation equipment, and other ancillary equipment. It covers the review of cleaning validation protocols to ensure effective cleaning processes.
3. Responsibilities
- Quality Assurance (QA) Manager: Responsible for overseeing the review process of cleaning validation protocols and ensuring that all equipment cleaning procedures meet regulatory and internal standards.
- Cleaning Validation Team: Responsible for developing, reviewing, and implementing cleaning validation protocols for all equipment used in tablet manufacturing.
- Production Team: Responsible for executing cleaning procedures and ensuring that equipment is thoroughly cleaned according to validated protocols.
- Regulatory Affairs: Ensures that cleaning validation protocols comply with applicable regulatory requirements, including GMP guidelines.
4. Accountability
The QA Manager is accountable for ensuring that cleaning validation protocols are reviewed and approved according to regulatory and internal standards. The Cleaning Validation Team is responsible for preparing and reviewing the protocols.
5. Procedure
5.1 Cleaning Protocol Development
- Develop cleaning validation protocols based on the type of equipment, the nature of the products manufactured, and any potential cross-contamination risks.
- Ensure that the protocols address critical cleaning parameters, including the cleaning agents used, cleaning methods, and validation testing procedures (Annexure-1).
- The cleaning protocol must define the acceptance criteria for the cleanliness of equipment, including limits for residues, visual inspection, and microbial contamination.
5.2 Review of Cleaning Validation Protocols
- QA must review cleaning validation protocols to ensure that they meet all regulatory requirements and internal standards for equipment cleanliness.
- Ensure that the protocols include detailed procedures for sampling, testing, and documenting cleaning activities, as well as clear acceptance criteria for cleanliness (Annexure-2).
- Review the choice of cleaning agents and methods to ensure they are appropriate for the equipment and manufacturing processes.
- Ensure that the cleaning procedures are validated for their ability to remove residues and contaminants effectively, including substances from previous batches and cleaning agents themselves.
5.3 Validation of Cleaning Procedures
- Review the results of the cleaning validation study to ensure that the cleaning procedures have been validated under realistic manufacturing conditions.
- The cleaning validation study must include tests such as swab sampling for residues, rinse sampling for contaminants, and visual inspection for cleanliness (Annexure-3).
- Verify that the cleaning methods are capable of achieving the required level of cleanliness for the equipment after each cleaning cycle.
- Ensure that the validation study includes multiple runs to confirm the consistency of the cleaning process over time and across different equipment.
5.4 Approval of Cleaning Validation Protocols
- Once the cleaning validation protocol and study results have been reviewed and deemed acceptable, QA must approve the cleaning validation protocol for implementation in the manufacturing process (Annexure-4).
- Ensure that the approval includes an assessment of whether the cleaning protocol meets all relevant GMP and regulatory requirements for equipment cleanliness.
- Document all approvals and sign-offs, ensuring that the protocol is fully traceable for future audits and inspections.
5.5 Review of Ongoing Cleaning Validation
- Periodically review the cleaning validation protocols to ensure that they remain effective, particularly when there are changes in the manufacturing process or the type of products being produced.
- Ensure that any new equipment or changes to existing equipment are incorporated into the cleaning validation process, and that new validation protocols are developed as necessary (Annexure-5).
- Monitor cleaning performance over time through routine inspections and sampling to ensure that the cleaning process remains consistent and effective.
5.6 Documentation and Record Keeping
- Ensure that all cleaning validation protocols, reports, and approval documents are retained in a secure, organized, and easily accessible manner for the required retention period (Annexure-6).
- Maintain records of cleaning validations, including results from cleaning efficacy tests, and corrective actions taken if cleaning failures are identified.
- Ensure that all cleaning validation documentation is available for internal audits, regulatory inspections, and quality reviews.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- GMP: Good Manufacturing Practice
- CAPA: Corrective and Preventive Action
- IPQC: In-Process Quality Control
7. Documents
- Cleaning Validation Protocol (Annexure-1)
- Cleaning Validation Results (Annexure-2)
- Validation Study Report (Annexure-3)
- Approval Documents (Annexure-4)
- Review Log (Annexure-5)
- Cleaning Validation Records (Annexure-6)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ISO 9001 – Quality Management Systems
- 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 Validation Protocol
| Equipment | Cleaning Procedure | Validation Method | Acceptance Criteria |
|---|---|---|---|
| Tablet Press | Manual Cleaning | Swab Sampling | Residue < 10 ppm |
Annexure-2: Cleaning Validation Results
| Batch Number | Inspection Results | Cleaning Method | Compliance Status |
|---|---|---|---|
| Batch-12345 | Pass | Manual Cleaning | Compliant |
Annexure-3: Validation Study Report
| Test | Sample ID | Result | Conclusion |
|---|---|---|---|
| Swab Test | Sample-01 | Residue 8 ppm | Pass |
Annexure-4: Approval Documents
| Protocol ID | Approval Status | Approved By | Approval Date |
|---|---|---|---|
| CVP-001 | Approved | John Doe | 01/04/2026 |
Annexure-5: Review Log
| Review Date | Reviewed By | Review Comments | Action Taken |
|---|---|---|---|
| 01/02/2026 | Jane Smith | Protocol updated for new equipment | Completed |
Annexure-6: Cleaning Validation Records
| Validation ID | Cleaning Method | Result | Validation Date |
|---|---|---|---|
| CV-001 | Manual Cleaning | Pass | 01/03/2026 |
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 validation protocol | Revised cleaning methods | QA Head |