SOP Guide for Pharma

Tablets: SOP for Cleaning Validation Swab Analysis in Quality Control – V 2.0

Auditor

Tablets: SOP for Cleaning Validation Swab Analysis in Quality Control – V 2.0

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

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.

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5. Procedure

5.1 Sample Collection

  1. 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).
  2. Ensure that the swabs are properly labeled to maintain traceability to the specific equipment, batch, and cleaning procedure.
  3. Collect at least two swabs from each equipment surface, depending on the validation protocol and the surface area.

5.2 Swab Preparation

  1. Prepare the swab by moistening it with an appropriate solvent (e.g., water for injection, 70% ethanol) as per the cleaning validation protocol.
  2. Ensure that the swab is fully wetted to efficiently collect any residual contaminants from the equipment surface.

5.3 Performing the Swab Analysis

  1. 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.
  2. 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).
  3. Perform the analysis in triplicate to ensure reliable and reproducible results.

5.4 Data Recording and Calculation

  1. Record the results of the swab analysis, including the quantity of the contaminant detected, in the batch record (Annexure-1).
  2. Calculate the residue concentration based on the swab sample results, using the following formula:
    • Residue Concentration = (Sample Concentration / Swab Area) × Swab Recovery
  3. 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.
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5.5 Acceptance Criteria

  1. 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.
  2. If the residue level exceeds the allowable limit, document the deviation in the deviation report (Annexure-2) and initiate a thorough investigation.
  3. 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

  1. Document the results of the cleaning validation swab analysis, including the test method, swab samples, and results, in the batch record (Annexure-1).
  2. Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
  3. Maintain raw data, test results, and supporting documentation for regulatory compliance and future reference.

5.7 Post-Test Cleanup

  1. Clean all equipment used for cleaning validation swab testing, including sample containers, HPLC instruments, and any other analysis apparatus, according to the cleaning SOP.
  2. Ensure that all equipment is properly maintained and calibrated for future use.
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6. Abbreviations

7. Documents

  1. Batch Record (Annexure-1)
  2. Deviation Report (Annexure-2)

8. References

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
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