Standard Operating Procedure for Visual Evaluation of Gel Batch Quality
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/068/2025 |
| Supersedes | SOP/GM/068/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 02/06/2025 |
| Effective Date | 04/06/2025 |
| Review Date | 02/06/2026 |
1. Purpose
To establish a uniform procedure for conducting visual inspection of gel batches during manufacturing and post-homogenization stages to ensure aesthetic quality and identify any non-conformities before release for packaging.
2. Scope
This SOP applies to all batches of gel formulations manufactured at the
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
- Withdraw approximately 100g from each major portion of the batch (top, middle, bottom).
- Place on a clean inspection tray under white light.
- 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
- Place the sample on the tray and view under light at different angles.
- Check for suspended particles, fibers, or air entrapment.
- Visually compare with retained samples or approved standard batch.
- Document all findings in Annexure-1.
- 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
- Visual Inspection Checklist – Annexure-1
- 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 |