Standard Operating Procedure for Cleaning Validation During Process Validation
| Department | Capsule Manufacturing |
|---|---|
| SOP No. | SOP/CM/160/2025 |
| Supersedes | SOP/CM/160/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 01/02/2025 |
| Effective Date | 05/02/2025 |
| Review Date | 01/02/2026 |
1. Purpose
The purpose of this SOP is to outline the procedures for cleaning validation during process validation in capsule manufacturing. This process ensures that all equipment used in the production of capsules is thoroughly cleaned between batches to prevent cross-contamination and ensure product quality. It ensures that cleaning procedures are effective, reproducible, and compliant with GMP and regulatory requirements.
2. Scope
This SOP applies to the cleaning validation procedures that must be followed during the process validation of capsule manufacturing. It covers the cleaning of all equipment used in capsule production, including capsule filling machines, coating equipment, and any other devices that come in contact with the product.
3. Responsibilities
- Production Operators: Responsible for following the SOP during the cleaning process, ensuring that all equipment is cleaned thoroughly as per the validated procedure.
- Quality Control (QC) Team: Responsible for performing sampling and testing of cleaned equipment to ensure compliance with cleanliness standards.
- Quality Assurance (QA) Team: Responsible for reviewing and approving the cleaning validation results, ensuring that the process complies with GMP and regulatory standards.
- Engineering Team: Responsible for ensuring that cleaning equipment is calibrated and functioning correctly during validation.
4. Accountability
The Capsule Manufacturing Supervisor is responsible for ensuring that cleaning validation is conducted in compliance with this SOP. The QA Manager is responsible for reviewing and approving the cleaning validation results and ensuring that the cleaning process complies with GMP and regulatory standards.
5. Procedure
5.1 Preparation for Cleaning Validation
Before initiating the cleaning validation process, ensure the following preparations are made:
-
Review Validation Plan
- Review the cleaning validation plan, which should include the equipment to be cleaned, cleaning agents to be used, cleaning parameters, and acceptance criteria. Ensure that the plan is approved by the QA department before starting the validation process.
-
Gather Materials and Equipment
- Ensure that all cleaning materials, including cleaning agents, tools, and equipment, are available and meet the quality specifications for the validation process.
- Ensure that all equipment to be cleaned, such as capsule filling machines and coating systems, is available and ready for validation.
-
Calibrate Equipment
- Ensure that all cleaning equipment, including water treatment systems and cleaning systems, is calibrated and functioning properly. Record calibration details in the Equipment Calibration Log (Annexure 1).
5.2 Cleaning Validation Process
Follow these steps to validate the cleaning process:
-
Pre-Cleaning Setup
- Set up the cleaning system according to the cleaning validation plan. Ensure that the cleaning agents, temperatures, and times are appropriately set for the validation run.
- Ensure that the cleaning equipment is properly configured to clean all surfaces of the manufacturing equipment, including those that come in contact with the product.
-
Start the Cleaning Process
- Begin the cleaning process by applying the cleaning agents to the equipment. Ensure that the process is carried out for the specified duration and under the required conditions.
- Record all relevant cleaning parameters, such as cleaning time, temperature, and concentration of cleaning agents, in the Cleaning Validation Log (Annexure 2).
-
Post-Cleaning Rinse
- After cleaning, perform a rinse with appropriate solutions to remove any residual cleaning agents from the equipment.
- Document the post-cleaning rinse in the Cleaning Validation Log (Annexure 2) and ensure that all equipment is rinsed thoroughly to prevent contamination.
-
Sampling and Testing
- Take samples from cleaned equipment to test for any residual contaminants, including cleaning agents, product residues, and microbial contamination.
- Perform tests on the samples, including swab tests, rinse water tests, and visual inspections for cleanliness. Record the results in the Cleaning Validation Report (Annexure 3).
-
Review Results
- Review the results of the testing to ensure that all equipment meets the established cleanliness standards. If any deviations or non-conformances are identified, investigate the cause and take corrective actions.
- If the equipment passes the validation criteria, approve the cleaning process for routine use. If the process does not meet the acceptance criteria, revalidate the process and perform corrective actions.
5.3 Post-Validation Documentation
Ensure proper documentation of the cleaning validation process:
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Cleaning Validation Report
- Prepare the Cleaning Validation Report (Annexure 4) summarizing the cleaning activities, results, and any corrective actions taken during the process.
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Approval of Validation Results
- Review and approve the validation report to ensure that all data meets the validation criteria. The report should be signed and approved by the QA Manager.
5.4 Documentation
Ensure proper documentation of the cleaning process for traceability and regulatory compliance:
-
Cleaning Validation Log
- Document all cleaning parameters, including cleaning time, temperature, and concentrations of cleaning agents, in the Cleaning Validation Log (Annexure 2).
-
Cleaning Validation Report
- Document the results of cleaning validation testing in the Cleaning Validation Report (Annexure 3).
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Validation Approval
- Ensure the Cleaning Validation Report (Annexure 4) is signed and approved by the QA Manager and is stored for future reference.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
- API: Active Pharmaceutical Ingredient
7. Documents
- Annexure 1: Equipment Calibration Log
- Annexure 2: Cleaning Validation Log
- Annexure 3: Cleaning Validation Report
- Annexure 4: Final Cleaning Validation Report
8. References
- FDA Guidelines on Cleaning and Sanitization
- Good Manufacturing Practice (GMP) Guidelines
- USP <1072> – Cleaning Procedures
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 Calibration Log
| Equipment ID | Calibration Date | Operator | Calibration Details | Next Calibration Due |
|---|---|---|---|---|
| Filling Machine 305 | 01/02/2025 | John Doe | Sealing and fill volume calibration | 01/02/2026 |
Annexure 2: Cleaning Validation Log
| Batch ID | Cleaning Date | Operator | Cleaning Parameters | Remarks |
|---|---|---|---|---|
| Batch 001 | 02/02/2025 | Jane Smith | Temperature: 50°C, Time: 30 minutes | No issues |
Annexure 3: Cleaning Validation Report
| Batch ID | Test Date | Test Type | Results | Remarks |
|---|---|---|---|---|
| Batch 001 | 02/02/2025 | Swab Test | Pass | No contamination detected |
Annexure 4: Final Cleaning Validation Report
| Batch ID | Validation Date | Operator | Validation Results | Action Taken |
|---|---|---|---|---|
| Batch 001 | 02/02/2025 | John Doe | Pass | Approved for production |
12. Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial version of SOP | Creation of SOP for cleaning validation during process validation | QA Head |
| 01/02/2025 | 2.0 | Updated cleaning process parameters and added new validation steps | Process optimization and addition of new validation protocols | QA Head |