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:
  • Sterile swabs
  • Pre-measured solvent (water, ethanol, or buffer solution)
  • Sterile sample collection tubes
  • Personal protective equipment (PPE)
• Label sample collection tubes before sampling.

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