Procedure for Ensuring Validation of All Surfaces

Department	Quality Assurance (QA)/Validation/Quality Control (QC)/Production
SOP No.	SOP/Ointment/130
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 ensuring validation of all surfaces that come into contact with products, cleaning agents, and environmental conditions in ointment manufacturing. This ensures cleaning effectiveness, prevents cross-contamination, and maintains regulatory compliance.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Validation, Quality Control (QC), and Production departments responsible for validating equipment, workbenches, storage surfaces, and facility areas.

3. Responsibilities

• QA Officer: Ensures validation protocols include all critical surfaces.
• Validation Team: Develops, executes, and maintains surface validation records.
• QC Analyst: Conducts analytical testing on surface swabs and rinse samples.
• Production Supervisor: Ensures adherence to validated cleaning protocols.
• QA Manager: Approves final validation reports and maintains documentation.

4. Accountability

The QA and Validation Managers are accountable for ensuring that all surfaces requiring validation are identified, tested, and validated per GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Identification of Surfaces for Validation

• Determine all surfaces requiring validation, including:
  • Product contact surfaces (mixing tanks, filling lines, nozzles, storage containers)
  • Cleaning agent contact surfaces
  • Environmental surfaces (workbenches, floors, walls, HVAC ducts)
  • Personnel contact surfaces (gloves, uniforms, equipment handles)
• Classify surfaces based on contamination risk levels.

5.2 Validation Methodology

• Select appropriate validation techniques for each surface:
  • Swab sampling for product residues
  • Rinse sampling for cleaning agent residues
  • Total Organic Carbon (TOC) testing for organic contamination
  • Microbial testing for environmental monitoring
• Define sampling frequency and locations for each surface type.

5.3 Execution of Surface Validation

• Perform visual inspection before sampling.
• Conduct swab sampling in designated high-risk areas.
• Collect rinse samples from equipment and storage surfaces.
• Submit collected samples to QC for analytical testing.

5.4 Analytical Testing and Compliance

• Analyze swab and rinse samples using:
  • HPLC for detecting active pharmaceutical ingredients (APIs)
  • TOC analysis for detecting residual organic material
  • pH testing for neutralizing agent residues
  • Microbial testing for detecting potential contamination
• Compare results with established acceptance limits.

5.5 Handling Deviations

• If any surface fails validation criteria:
  • Re-clean the affected area and perform repeat testing.
  • Investigate potential sources of contamination.
  • Implement corrective and preventive actions (CAPA).

5.6 Documentation and Review

• Record all validation data in the Surface Validation Log.
• QA must review and approve all validation results.
• Maintain validation records for regulatory audits.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• TOC – Total Organic Carbon
• HPLC – High-Performance Liquid Chromatography

7. Documents

• Surface Validation Protocol (Annexure-1)
• Surface Validation Log (Annexure-2)

8. References

• ICH Q7 – Good Manufacturing Practice Guide
• WHO Guidelines for Cleaning Validation
• 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: Surface Validation Protocol

Surface Type	Sampling Method	Test Performed	Acceptance Criteria
Mixing Tanks	Swab Sampling	HPLC	< 10 ppm API residue
Filling Lines	Rinse Sampling	TOC Analysis	< 5 ppm organic residue
Storage Containers	Swab Sampling	Microbial Testing	No growth detected

Annexure-2: Surface Validation Log

Date	Surface ID	Sampling Method	Test Performed	Result	Reviewed By
01/02/2025	MIX-1001	Swab	HPLC	Pass	QA Manager
02/02/2025	FILL-2002	Rinse	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