SOP is applicable to all gel formulations developed, tested, or manufactured at the Gel Manufacturing Department, specifically during the product development, scale-up, or batch release stages.

3. Responsibilities

• Formulation Development Team: Design and modify gel composition to optimize texture and spreadability.
• QC Department: Perform physical evaluations and document data.
• QA Department: Ensure SOP adherence and approve necessary deviations.

4. Accountability

The Head of Gel Manufacturing is accountable for ensuring the implementation of this SOP. The QA Head is responsible for compliance and documentation review.

5. Procedure

5.1 Definition of Texture and Spreadability

Texture refers to the sensory attributes (e.g., smoothness, tackiness, greasiness) perceived during gel application. Spreadability indicates the ease with which the gel spreads over the skin or target area.

5.2 Instruments and Equipment

• Texture Analyzer (e.g., TA.XT Plus)
• Glass slides and fixed weights for spreadability test
• Stopwatch and caliper

5.3 Sampling

1. Take representative samples (approx. 5 g) from the batch under evaluation.
2. Ensure samples are free of air bubbles and stored in inert containers.

5.4 Texture Analysis Procedure

1. Calibrate Texture Analyzer according to the manufacturer’s instruction manual.
2. Use a cylindrical probe (e.g., 25 mm diameter) for penetration testing.
3. Test parameters:
   • Probe speed: 1 mm/s
   • Penetration depth: 10 mm
   • Hold time: 5 seconds
4. Record hardness, cohesiveness, adhesiveness, and springiness of the gel.

5.5 Spreadability Test Procedure

1. Place 1 g of gel between two glass slides.
2. Apply 500 g weight for 5 minutes.
3. Measure the diameter of spread using a caliper.
4. Repeat the process in triplicate and average the readings.

5.6 Acceptance Criteria

• Hardness: 200–500 g
• Spread Diameter: 4–7 cm under 500 g load
• Adhesiveness: Not more than -30 g·s

5.7 Data Recording and Documentation

• Log all texture readings in the Texture Analysis Record Sheet (Annexure-1).
• Record spreadability data in the Spread Test Logbook (Annexure-2).
• Compare results with development targets or specification sheets.

6. Abbreviations

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

7. Documents

1. Texture Analysis Record Sheet – Annexure-1
2. Spread Test Logbook – Annexure-2
3. Product Development Specification Sheet – Annexure-3

8. References

• ICH Q8 (R2) – Pharmaceutical Development
• USP General Chapter <915> – Spreadability Test
• Texture Profile Analysis Guidelines – Brookfield/Stable Micro Systems

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: Texture Analysis Record Sheet

Date	Batch No.	Hardness	Adhesiveness	Cohesiveness	Springiness
01/06/2025	GL-018	350 g	-25 g·s	0.75	0.92

Annexure-2: Spread Test Logbook

Date	Sample Code	Weight Applied	Spread Diameter (cm)	Average Spread
01/06/2025	GEL018A	500 g	6.3	6.2

Annexure-3: Product Development Specification Sheet

Parameter	Target	Observed	Status
Hardness	300–450 g	350 g	Pass
Spread Diameter	5–7 cm	6.3 cm	Pass

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/06/2022	1.0	Initial SOP Released	New SOP	QA Head
02/06/2025	2.0	Updated Spreadability Parameters	Annual Review	QA Head