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