Procedure for Validation of Cleaning Detergents

Department	Quality Assurance (QA)/Validation/Quality Control (QC)/Production
SOP No.	SOP/Ointment/125
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 validation process for cleaning detergents used in ointment manufacturing. This ensures that selected detergents effectively remove residues, do not introduce contaminants, and comply with regulatory requirements.

2. Scope

This SOP applies to all personnel in the Quality Assurance (QA), Validation, Quality Control (QC), and Production departments responsible for selecting, testing, and validating cleaning detergents.

3. Responsibilities

• QA Officer: Ensures validation activities align with regulatory requirements.
• Validation Team: Develops detergent validation protocols and executes validation studies.
• QC Analyst: Conducts analytical testing on detergent residues.
• Production Supervisor: Ensures proper use of validated detergents during cleaning.
• QA Manager: Approves detergent validation reports and ensures compliance.

4. Accountability

The QA and Validation Managers are accountable for ensuring that detergent validation is conducted as per GMP, FDA, ICH, and WHO guidelines.

5. Procedure

5.1 Selection of Cleaning Detergents

• Choose cleaning detergents based on:
  • Effectiveness in removing residues
  • Compatibility with equipment materials
  • Ease of rinsing and removal
  • Non-toxicity and safety for operators
  • Environmental impact
• Review detergent specifications from manufacturers.
• Obtain Material Safety Data Sheets (MSDS) and Certificates of Analysis (CoA).

5.2 Validation of Cleaning Detergent Effectiveness

• Develop a Cleaning Detergent Validation Protocol (CDVP).
• Define acceptance criteria, including:
  • Removal efficiency (% residue removed)
  • pH compatibility with equipment
  • Rinseability (no residual detergent detected)
• Perform laboratory-scale testing using analytical methods such as:
  • Total Organic Carbon (TOC) Analysis
  • High-Performance Liquid Chromatography (HPLC)
  • pH Testing
  • Visual Inspection

5.3 Execution of Cleaning Trials

• Conduct cleaning validation trials on actual manufacturing equipment.
• Use the selected detergent under standard operating conditions.
• Collect swab and rinse samples for residue testing.
• Compare test results with predefined acceptance limits.

5.4 Residue Analysis and Compliance

• Test for detergent residues using:
  • Swab sampling
  • Rinse sampling
  • UV Spectroscopy
  • Microbial Analysis (if applicable)
• Ensure that detected residues are below established limits.
• Document and review results before final approval.

5.5 Handling Deviations

• If detergent validation fails:
  • Identify root cause (e.g., inadequate rinsing, incompatibility).
  • Modify cleaning procedures if needed.
  • Repeat validation with adjusted parameters.
• All deviations must be documented, and corrective actions must be implemented.

5.6 Final Validation Report and Approval

• Summarize detergent validation results and compliance status.
• QA and Validation teams must approve the final report.
• Maintain detergent 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

• Cleaning Detergent Validation Protocol (Annexure-1)
• Cleaning Detergent Validation Report (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: Cleaning Detergent Validation Protocol

Test Parameter	Method	Acceptance Criteria
Residue Removal Efficiency	HPLC	> 99%
pH Compatibility	pH Meter	Neutral
Rinseability	TOC Analysis	< 5 ppm

Annexure-2: Cleaning Detergent Validation Report

Date	Detergent Name	Test Performed	Result	Reviewed By
01/02/2025	Detergent-X	HPLC	Pass	QA Manager
02/02/2025	Detergent-Y	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