Procedure for Evaluating Sensory Attributes of Ointments

Department	Research and Development (R&D)/Quality Assurance (QA)/Quality Control (QC)/Formulation Development
SOP No.	SOP/Ointment/183
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 a systematic approach for evaluating the sensory attributes of pharmaceutical ointments. Sensory evaluation is crucial for ensuring patient acceptability, product consistency, and compliance with regulatory guidelines.

2. Scope

This SOP applies to all personnel involved in the formulation, development, testing, and validation of ointment sensory attributes in the Research and Development (R&D), Quality Assurance (QA), and Quality Control (QC) departments.

3. Responsibilities

• Formulation Scientist: Develops and optimizes the sensory properties of ointments.
• QA Officer: Ensures adherence to sensory evaluation guidelines.
• QC Analyst: Conducts physical and sensory testing.
• R&D Supervisor: Oversees the sensory evaluation process.
• Regulatory Affairs Specialist: Ensures compliance with sensory testing documentation.

4. Accountability

The R&D Manager is accountable for ensuring that all sensory evaluation activities comply with GMP, FDA, ICH, WHO, and company policies.

5. Procedure

5.1 Selection of Sensory Attributes for Evaluation

• The following sensory attributes should be evaluated for ointments:
  • Appearance: Color, uniformity, phase separation.
  • Odor: Acceptability and absence of off-smells.
  • Texture: Smoothness, grittiness, uniformity.
  • Spreadability: Ease of application on the skin.
  • Residue: Greasiness, stickiness, or dryness after application.

5.2 Preparation for Sensory Evaluation

• Select a **representative batch** of the ointment for testing.
• Ensure that **testing personnel are trained** in sensory evaluation techniques.
• Maintain a **controlled testing environment**, including:
  • Neutral lighting.
  • Temperature control at **25°C ± 2°C**.
  • Humidity control at **45% ± 5% RH**.
• Prepare evaluation sheets based on a **Sensory Assessment Scale (Annexure-1).**

5.3 Sensory Testing Process

• Dispense a standard quantity of the ointment onto a **test substrate (e.g., skin, artificial membrane).**
• Conduct evaluations in the following order:
  • Visual Inspection: Observe color, consistency, and phase separation.
  • Odor Test: Sniff the sample and assess odor intensity.
  • Texture Assessment: Rub a small amount between fingers.
  • Spreadability Test: Apply on a test area and note ease of spreading.
  • Residue Analysis: Observe skin feel after 10 minutes.
• Each parameter is rated using a **5-point scale** (1 = Poor, 5 = Excellent).
• Record observations in the **Sensory Evaluation Log (Annexure-2).**

5.4 Handling Sensory Evaluation Deviations

• If any attribute falls below an acceptable score:
  • Identify the root cause (e.g., formulation issue, ingredient quality).
  • Adjust formulation parameters (e.g., change emulsifier, modify viscosity).
  • Conduct re-evaluation after modifications.
• Document all changes in the **Sensory Evaluation Deviation Log (Annexure-3).**

5.5 Approval for Production

• QA must review and approve sensory evaluation results.
• Only formulations that meet **minimum sensory quality criteria** proceed to manufacturing.

5.6 Periodic Review and Improvement

• Conduct **quarterly reviews** of sensory attributes.
• Implement improvements based on **customer feedback and market trends.**
• Maintain records for **five years** for regulatory compliance.

6. Abbreviations

• GMP – Good Manufacturing Practices
• QA – Quality Assurance
• QC – Quality Control
• ICH – International Council for Harmonisation
• FDA – Food and Drug Administration

7. Documents

• Sensory Assessment Scale (Annexure-1)
• Sensory Evaluation Log (Annexure-2)
• Sensory Evaluation Deviation Log (Annexure-3)

8. References

• ICH Q8 – Pharmaceutical Development Guidelines
• WHO Guidelines on Sensory Testing in Pharmaceuticals
• FDA Guidance on Topical Drug Product Development

9. SOP Version

Version 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Sensory Assessment Scale

Attribute	Score (1-5)	Comments
Appearance
Odor
Texture
Spreadability
Residue

Annexure-2: Sensory Evaluation Log

Date	Batch No.	Parameter	Score	QA Approval
02/02/2025	OINT-1001	Spreadability	4.5	Approved

Annexure-3: Sensory Evaluation Deviation Log

Date	Batch No.	Issue	Corrective Action	QA Approval
02/02/2025	OINT-1001	Excess Greasiness	Adjusted Emulsifier	Approved