Gel Manufacturing: SOP for Cleaning Validation of Manufacturing Tanks for Gel Formulations – V 2.0

Auditor

7 months ago

Standard Operating Procedure for Cleaning Validation of Manufacturing Tanks in Gel Manufacturing

Department	Gel Manufacturing
SOP No.	SOP/GM/162/2025
Supersedes	SOP/GM/162/2022
Page No.	Page 1 of 12
Issue Date	09/06/2025
Effective Date	11/06/2025
Review Date	09/06/2027

1. Purpose

To establish a standard procedure for performing cleaning validation of manufacturing tanks used in gel production, ensuring effective removal of product residues, cleaning agents, and microorganisms as per regulatory expectations.

2. Scope

This SOP is applicable to all stainless-steel manufacturing tanks used for producing gel formulations in the Gel Manufacturing department.

3. Responsibilities

Production Personnel: Perform cleaning and assist during validation runs.
QA Personnel: Prepare and approve validation protocol and report.
QC Personnel: Conduct analytical testing of swab/rinse samples.
Validation Officer: Coordinate execution

of validation activities and data collection.

4. Accountability

Head – Manufacturing and Head – Quality Assurance are accountable for validation compliance and ensuring documentation is maintained.

5. Procedure

5.1 Preparation and Approval of Validation Protocol

QA prepares the cleaning validation protocol describing objective, scope, sampling points, methods, and acceptance criteria.
Protocol shall be reviewed by QC and approved by QA and Production Heads.

5.2 Cleaning Procedure

Follow the approved SOP for cleaning of manufacturing tanks using validated cleaning agents (e.g., purified water, caustic solution).
Rinse all surfaces thoroughly to remove cleaning agents.
Perform visual inspection for cleanliness post-cleaning.

5.3 Sampling Procedure

Identify and mark worst-case locations for swab sampling such as tank bottom, manhole gasket, agitator shaft, and inner walls.
Collect swabs using pre-validated kits and follow aseptic techniques.
If required, collect rinse samples (e.g., final rinse water) and test for residues.

5.4 Analytical Testing

QC performs residue testing using HPLC, UV spectroscopy, TOC, and microbial analysis.
Compare results against pre-defined MACO limits and microbial specifications.

5.5 Evaluation and Documentation

QA and Validation Officer review data and confirm all acceptance criteria are met.
Document results in Cleaning Validation Report (Annexure-3) along with analytical attachments.
At least three successful consecutive validations are required for final qualification.

6. Abbreviations

HPLC: High Performance Liquid Chromatography
MACO: Maximum Allowable Carryover
TOC: Total Organic Carbon
QA: Quality Assurance
QC: Quality Control

7. Documents

Cleaning Validation Protocol – Annexure-1
Sampling Logbook – Annexure-2
Cleaning Validation Report – Annexure-3

8. References

ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
EU Guidelines: Volume 4, Annex 15: Qualification and Validation
WHO TRS 1019 Annex 3: Cleaning Validation Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Jr. Production Chemist	QA Executive	Head – Manufacturing
Department	Gel Manufacturing	Quality Assurance	Manufacturing

11. Annexures

Annexure-1: Cleaning Validation Protocol Format

Protocol No.
Equipment ID
Tank Capacity
Cleaning Method	CIP / Manual
Cleaning Agent
Sampling Locations
Analytical Method
Acceptance Criteria

Annexure-2: Sampling Log Format

Sample No.	Sampling Location	Date	Collected By	Remarks

Annexure-3: Cleaning Validation Report Format

Report No.
Execution Date
Results Summary
Deviations
Corrective Actions
Conclusion
QA Review Comments

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
18/03/2022	1.0	Initial Release	New SOP	QA Head
09/06/2025	2.0	Inclusion of rinse sampling & TOC	Annual SOP Review	QA Head