Gel Manufacturing Department and subject to visual inspection prior to transfer or filling.

3. Responsibilities

• Production Chemist: Conducts the initial visual inspection and records observations.
• QA Inspector: Performs verification and signs off inspection reports.
• Head – Manufacturing: Approves batch status based on inspection findings.

4. Accountability

The Head – Manufacturing shall be accountable for ensuring implementation and compliance with this SOP.

5. Procedure

5.1 Inspection Timing

• After homogenization and deaeration.
• Prior to filling or packaging.
• During in-process sampling (as required).

5.2 Materials and Tools Required

• White inspection tray or stainless steel tray
• Adequate lighting (minimum 600 lux)
• Magnifying glass (optional)
• Visual Inspection Checklist (Annexure-1)
• Clean glass rod for stirring

5.3 Sample Preparation

1. Withdraw approximately 100g from each major portion of the batch (top, middle, bottom).
2. Place on a clean inspection tray under white light.
3. Stir gently to release entrapped air bubbles.

5.4 Inspection Parameters

Parameter	Criteria
Color	Uniform; no discoloration or dark spots
Clarity	Transparent or as per product specification
Air Bubbles	Minimal to none
Phase Separation	None visible
Foreign Particles	Absent
Consistency	Homogeneous gel structure

5.5 Execution Steps

1. Place the sample on the tray and view under light at different angles.
2. Check for suspended particles, fibers, or air entrapment.
3. Visually compare with retained samples or approved standard batch.
4. Document all findings in Annexure-1.
5. Attach photographic evidence for critical observations, if applicable.

5.6 Action on Observations

• If visual anomalies are detected, quarantine the batch immediately.
• Initiate deviation report and inform QA for further investigation.
• Rework or rejection decisions to be taken per QA approval.

6. Abbreviations

• QA: Quality Assurance
• SOP: Standard Operating Procedure
• QC: Quality Control

7. Documents

1. Visual Inspection Checklist – Annexure-1
2. Deviation Form – Annexure-2

8. References

• Internal Product Specifications
• ICH Q6A 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: Visual Inspection Checklist

Batch No.
Product Name
Date
Inspected By
Color Uniformity	[ ] Pass [ ] Fail
Air Bubble Presence	[ ] None [ ] Minor [ ] Excessive
Foreign Particles	[ ] Absent [ ] Present
Phase Separation	[ ] None [ ] Observed
Consistency	[ ] Homogeneous [ ] Non-Homogeneous
Remarks
Signature

Annexure-2: Deviation Form

Deviation No.
Reported Date
Observed By
Nature of Deviation
Immediate Action Taken
Root Cause (if known)
Disposition Decision
Approved By (QA)

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
10/06/2022	1.0	Initial Issue	New SOP	QA Head
02/06/2025	2.0	Included photographic documentation requirement	Periodic Review	QA Head