Procedure for Visual Inspection of Ointments
| Department | Quality Control (QC)/Quality Assurance (QA)/Production |
|---|---|
| SOP No. | SOP/Ointment/065 |
| 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 method for performing visual inspection of ointments to ensure product quality, uniformity, and compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel in the Quality Control (QC), Quality Assurance (QA), and Production departments responsible for conducting visual inspections of ointments during in-process control, finished product evaluation, and batch release.
3. Responsibilities
- Quality Control Analyst: Conducts visual inspection and records observations.
- Quality Assurance Personnel: Verifies and approves inspection results.
- Production Supervisor: Ensures that ointment batches conform to visual inspection criteria.
- R&D Team (if applicable): Investigates deviations and suggests corrective actions.
4. Accountability
The QC and QA Managers are accountable for ensuring that visual inspections are conducted accurately and documented as per regulatory and GMP standards.
5. Procedure
5.1 Equipment and Materials
- Standardized visual inspection area with appropriate lighting
- White and black background plates
- Magnifying glass (if required)
- Clean glass containers for sample observation
- Sample collection tools
- Data recording sheets
5.2 Pre-Inspection Preparations
- Ensure that the inspection area is free from dust and contaminants.
- Adjust lighting to a minimum of 1000 lux.
- Inspect
ointment samples at room temperature (25°C ± 2°C).
Ensure personnel wear gloves and other protective equipment.
5.3 Visual Inspection Criteria
- Appearance: The ointment should have a uniform texture and color.
- Foreign Particles: The sample should be free from visible contamination.
- Phase Separation: No sign of oil or water phase separation should be observed.
- Clumping or Grittiness: The formulation should be smooth and free from lumps.
- Color Consistency: Should match the reference standard for the product.
- Air Bubbles: The product should be free from excessive trapped air.
- Odor: The ointment should have the expected scent and no off-odor.
5.4 Inspection Method
- Take a representative sample from the batch.
- Place a small amount on a white background plate and observe under adequate lighting.
- Check for uniformity, color, and presence of any foreign particles.
- Perform a secondary check on a black background plate for contrast detection.
- Use a magnifying glass if necessary to examine smaller particles.
- Record observations in the Visual Inspection Log.
5.5 Acceptance Criteria
- The ointment should be uniform in texture and free from any visual defects.
- No foreign particles or phase separation should be observed.
- Any deviations must be investigated and documented.
5.6 Documentation
- Record all visual inspection observations in the Visual Inspection Log.
- Document batch numbers and inspection parameters.
- QA personnel must review and approve results before batch release.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
7. Documents
- Visual Inspection Log (Annexure-1)
- Ointment Batch Inspection Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- USP <790> – Visible Particulates in Injections
- ICH Q6A – Specifications: Test Procedures and Acceptance Criteria
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Visual Inspection Log
| Date | Batch Number | Sample Description | Observations | Result | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Uniform, white ointment | No visible defects | Pass | QA Officer |
| 02/02/2025 | OINT-102 | Off-white, smooth texture | No foreign particles | Pass | QA Officer |
Annexure-2: Ointment Batch Inspection Report
| Date | Batch Number | Inspection Criteria | Acceptance Criteria | Result | Final Status | Approved By |
|---|---|---|---|---|---|---|
| 01/02/2025 | OINT-101 | Appearance | Uniform, smooth | Pass | Approved | QA Head |
| 02/02/2025 | OINT-102 | Foreign Particles | None visible | Pass | Approved | QA Head |
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 |