of cleaning validation and routine monitoring programs.

2. Scope

This SOP is applicable to the Analytical Method Development (AMD) department for developing swab-based sampling methods for pharmaceutical manufacturing equipment, contact parts, cleanroom surfaces, and product exposure areas.

3. Responsibilities

• Analytical Scientist: Designs swabbing protocol and validates swab method for chemical residues or microbial contamination.
• QC Analyst: Performs method verification and participates in recovery studies.
• QA Executive: Verifies documentation and approves method for GMP implementation.

4. Accountability

The Head of Analytical Method Development is accountable for ensuring validated swab sampling methods are implemented and documented in accordance with regulatory expectations.

5. Procedure

5.1 Selection of Swab Material

1. Select swabs made of low-lint polyester or polyurethane foam compatible with analyte and solvent system.
2. Ensure swab handles are inert and resistant to leaching.

5.2 Surface Material and Area Standardization

1. Use representative surface types: SS-316, glass, plastic, coated surfaces.
2. Mark a fixed sampling area, typically 25 cm² (5 cm × 5 cm), using a sterile template.

5.3 Spiking and Recovery Studies

1. Apply known quantity of analyte or microbial suspension to test surface and allow to dry completely.
2. Swab in a systematic pattern (horizontal, vertical, diagonal) with light pressure.
3. Transfer swab to test tube containing extraction solvent or diluent.
4. Agitate, sonicate, or vortex as per method protocol.

5.4 Analytical Detection

1. For chemical residue: Analyze using HPLC, UV, or TOC depending on analyte type.
2. For microbiological testing: Plate extract on suitable media and incubate.
3. Calculate recovery using:
   
   % Recovery = (Recovered / Spiked) × 100

5.5 Acceptance Criteria

1. Recovery should be ≥70% for chemical analytes and ≥50% for microbial recoveries unless justified otherwise.
2. % RSD for precision studies should be ≤15%.

5.6 Documentation

1. Document surface details, swabbing pattern, solvents used, spiking levels, and analytical results in Annexures.
2. Prepare final swab method validation report for QA approval.

6. Abbreviations

• SOP: Standard Operating Procedure
• TOC: Total Organic Carbon
• HPLC: High Performance Liquid Chromatography
• RSD: Relative Standard Deviation

7. Documents

1. Swab Recovery Test Worksheet – Annexure-1
2. Surface Area Mapping and Template Record – Annexure-2
3. Swab Method Validation Report – Annexure-3

8. References

• FDA Guidance for Industry: Cleaning Validation
• ICH Q7: GMP for Active Pharmaceutical Ingredients
• WHO TRS 937, Annex 4: Cleaning Validation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name	Shalini Rao	Deepak Jain	Sunita Reddy
Designation	Analytical Scientist	QA Reviewer	Head – AMD
Department	Analytical Method Development	QA	Analytical Method Development

11. Annexures

Annexure-1: Swab Recovery Test Worksheet

Analyte	Surface Type	Amount Spiked (µg)	Amount Recovered (µg)	Recovery (%)	Status
Paracetamol	SS-316	100	86	86%	Pass

Annexure-2: Surface Area Mapping

Equipment	Surface	Swab Area (cm²)	Swab Template Used
Granulator	Inside wall	25	Yes

Annexure-3: Swab Method Validation Report

Swab sampling method for Paracetamol residues validated on SS-316 surface. Recovery: 86%, RSD: 4.2%. Method meets acceptance criteria and is approved for GMP cleaning validation use.

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
21/05/2025	2.0	Updated with TOC detection and microbial recovery criteria	Annual Review and Method Expansion	Sunita Reddy
12/05/2022	1.0	Initial SOP Release	New SOP	QA Head