Procedure for Conducting Swab Sampling for Residue Testing
| Department | Quality Control (QC)/Quality Assurance (QA)/Validation |
|---|---|
| SOP No. | SOP/Ointment/124 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for conducting swab sampling for residue testing in ointment manufacturing. This ensures that equipment cleaning is effective and meets regulatory compliance requirements.
2. Scope
This SOP applies to all personnel in the Quality Control (QC), Quality Assurance (QA), and Validation departments responsible for performing and documenting swab sampling for residue testing.
3. Responsibilities
- QC Analyst: Conducts swab sampling and analyzes residue levels.
- QA Officer: Reviews test results and ensures compliance with acceptance criteria.
- Validation Team: Establishes swab sampling protocols and criteria.
- Production Supervisor: Ensures adherence to validated cleaning procedures.
- QA Manager: Approves swab sampling reports and ensures compliance.
4. Accountability
The QA and QC Managers are accountable for ensuring that swab sampling for residue testing is conducted as per GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Selection of Swab Sampling Locations
- Identify critical equipment surfaces for swab sampling.
- Focus on:
- Hard-to-clean areas
- Product contact surfaces
- Equipment joints and crevices
- Use a risk-based approach to determine sampling points.
5.2 Preparation for Swab Sampling
- Ensure all equipment is dry and
ready for sampling.
Prepare the necessary materials:
Label sample collection tubes before sampling.
- Sterile swabs
- Pre-measured solvent (water, ethanol, or buffer solution)
- Sterile sample collection tubes
- Personal protective equipment (PPE)
5.3 Execution of Swab Sampling
- Moisten the swab with the designated solvent.
- Swab the predefined surface using a consistent motion:
- First stroke: Horizontal motion
- Second stroke: Vertical motion
- Third stroke: Diagonal motion
- Rotate the swab to ensure full contact with the surface.
- Immediately transfer the swab into the labeled sample tube.
- Seal and transport samples to the laboratory for analysis.
5.4 Analytical Testing
- Analyze swab samples using one of the following methods:
- High-Performance Liquid Chromatography (HPLC)
- Total Organic Carbon (TOC) Analysis
- UV Spectroscopy
- Microbial Testing (if applicable)
- Record and analyze test results against predefined acceptance limits.
5.5 Acceptance Criteria
- Residue levels must be below established limits.
- Equipment must pass visual inspection before release.
- All deviations must be documented and investigated.
5.6 Handling Deviations
- If residue levels exceed acceptance criteria:
- Inform the QA and Production teams immediately.
- Initiate re-cleaning and document corrective actions.
- Repeat swab sampling and confirm compliance.
5.7 Documentation and Review
- Record test results in the Swab Sampling Log.
- QA must review and approve all test results before equipment release.
- Maintain all records for regulatory audits.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- HPLC – High-Performance Liquid Chromatography
- TOC – Total Organic Carbon
7. Documents
- Swab Sampling Protocol (Annexure-1)
- Swab Sampling Log (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice Guide
- WHO Guidelines for Residue Testing
- US FDA Guidance on Cleaning Validation
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Swab Sampling Protocol
| Test Parameter | Method | Acceptance Criteria |
|---|---|---|
| API Residue | HPLC | < 10 ppm |
| Organic Residue | TOC Analysis | < 5 ppm |
| Microbial Contamination | Cultural Test | No Growth |
Annexure-2: Swab Sampling Log
| Date | Equipment ID | Sample Location | Test Performed | Result | Reviewed By |
|---|---|---|---|---|---|
| 01/02/2025 | MIX-1001 | Tank Interior | HPLC | Pass | QA Manager |
| 02/02/2025 | FILL-2002 | Filling Nozzles | TOC | Pass | QA Manager |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |