Standard Operating Procedure for Cleaning Validation Swab Analysis in Quality Control
| Department | Quality Control |
|---|---|
| SOP No. | SOP/TAB/101/2025 |
| Supersedes | SOP/TAB/101/2022 |
| 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 performing cleaning validation swab analysis in the quality control laboratory, ensuring that equipment and surfaces are free from residual contaminants that could affect product quality.
2. Scope
This SOP applies to cleaning validation testing of equipment used in tablet manufacturing. It ensures that cleaning methods effectively remove residues of active pharmaceutical ingredients (API) and excipients.
3. Responsibilities
- Quality Control (QC): Responsible for performing the cleaning validation swab analysis, ensuring that all equipment surfaces meet residue limits specified in the cleaning validation protocol.
- Quality Assurance (QA): Ensures that the cleaning validation testing procedure is followed and reviews the results for compliance with regulatory and internal requirements.
- Cleaning Personnel: Responsible for carrying out the cleaning of equipment, ensuring it is properly cleaned according to the validated procedures.
4. Accountability
The QC Manager is accountable for ensuring that cleaning validation swab testing is conducted accurately and consistently. The QA Manager is
responsible for reviewing and approving the results.
5. Procedure
5.1 Sample Collection
- Collect swab samples from equipment surfaces after cleaning, as specified in the cleaning validation protocol (typically, from high-contact surfaces such as product contact areas).
- Ensure that the swabs are properly labeled to maintain traceability to the specific equipment, batch, and cleaning procedure.
- Collect at least two swabs from each equipment surface, depending on the validation protocol and the surface area.
5.2 Swab Preparation
- Prepare the swab by moistening it with an appropriate solvent (e.g., water for injection, 70% ethanol) as per the cleaning validation protocol.
- Ensure that the swab is fully wetted to efficiently collect any residual contaminants from the equipment surface.
5.3 Performing the Swab Analysis
- Analyze the swab samples using an appropriate analytical method (e.g., High-Performance Liquid Chromatography (HPLC), UV spectrophotometry, or other methods as specified in the protocol) to detect residues of the API or excipients.
- Ensure that the method is validated for the specific residues being tested, and use a sensitivity level that ensures detection of the contaminants within acceptable limits (e.g., ≤ 10 ppm).
- Perform the analysis in triplicate to ensure reliable and reproducible results.
5.4 Data Recording and Calculation
- Record the results of the swab analysis, including the quantity of the contaminant detected, in the batch record (Annexure-1).
- Calculate the residue concentration based on the swab sample results, using the following formula:
- Residue Concentration = (Sample Concentration / Swab Area) × Swab Recovery
- Ensure that the residue concentration is below the predetermined acceptance criteria, typically ≤ 10 ppm for the API and excipients combined, or as specified by regulatory guidelines.
5.5 Acceptance Criteria
- Ensure that the residue levels in the swab sample are within the acceptable limits defined in the cleaning validation protocol. Typically, this will be ≤ 10 ppm of the API and excipients combined, or as per the product specifications.
- If the residue level exceeds the allowable limit, document the deviation in the deviation report (Annexure-2) and initiate a thorough investigation.
- Take corrective actions as necessary and repeat the cleaning and testing process if required to meet the acceptance criteria.
5.6 Documentation and Record-Keeping
- Document the results of the cleaning validation swab analysis, including the test method, swab samples, and results, in the batch record (Annexure-1).
- Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
- Maintain raw data, test results, and supporting documentation for regulatory compliance and future reference.
5.7 Post-Test Cleanup
- Clean all equipment used for cleaning validation swab testing, including sample containers, HPLC instruments, and any other analysis apparatus, according to the cleaning SOP.
- Ensure that all equipment is properly maintained and calibrated for future use.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- API: Active Pharmaceutical Ingredient
- HPLC: High-Performance Liquid Chromatography
- ppm: Parts Per Million
- QA: Quality Assurance
7. Documents
- Batch Record (Annexure-1)
- Deviation Report (Annexure-2)
8. References
- USP <1223> – Validation of Cleaning Processes
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- European Pharmacopoeia (EP) – Cleaning Validation and Residue Testing
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Batch Record
| Batch Number | Swab Sample | Residue Detected (ppm) | Result |
|---|---|---|---|
| Batch 001 | Surface A | 0.2 | Pass |
Annexure-2: Deviation Report
| Deviation Date | Batch Number | Deviation Description | Corrective Action | Responsible Person |
|---|---|---|---|---|
| 15/12/2025 | Batch 001 | Residue exceeded limit | Re-clean and re-test the equipment | John Doe |
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 Sampling Method | Refined residue detection procedure | QA Head |