SOP for Testing Spreadability of Ointments – V 2.0
Procedure for Testing Spreadability of Ointments
| Department |
Quality Control (QC)/Quality Assurance (QA)/Production |
| SOP No. |
SOP/Ointment/068 |
| 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 establish a standardized method for testing the spreadability of ointments. Spreadability is a key parameter that determines the ease of application and uniformity of distribution on the skin, ensuring product efficacy and patient compliance.
2. Scope
This SOP applies to all personnel in the Quality Control (QC) and Quality Assurance (QA) departments responsible for testing the spreadability of ointments during formulation development and routine batch testing.
3. Responsibilities
- Quality Control Analyst: Conducts spreadability testing and records results.
- Quality Assurance Personnel: Reviews and approves test results.
- Production Supervisor: Ensures that the ointment batches conform to spreadability requirements.
- R&D Team (if applicable): Evaluates formulation modifications based on spreadability test results.
4. Accountability
The QC and QA Managers are accountable for ensuring that spreadability tests are conducted accurately and documented as per regulatory and GMP standards.
5. Procedure
5.1 Pre-Test Preparations
- Ensure that the ointment sample is at room temperature (25°C ± 2°C).
- Use a calibrated spreadability testing apparatus (such as a parallel plate method or glass slide method).
- Clean all equipment, glass plates, and measuring instruments before use.
- Ensure that the test surface is non-absorbent and free from contaminants.
5.2 Spreadability Testing Methods
5.2.1 Parallel Plate Method
- Weigh approximately 0.5 g to 1.0 g of ointment and place it in the center of the lower glass plate.
- Place a second glass plate on top of the ointment.
- Apply a known weight (e.g., 100 g, 200 g, or 500 g) onto the upper plate.
- Allow the weight to remain for 5 minutes.
- Measure the diameter of the spread ointment using a calibrated scale.
5.2.2 Glass Slide Method
- Place a small amount (approx. 0.5 g) of ointment on a fixed glass slide.
- Press another slide on top and allow uniform spreading under its own weight.
- After 5 minutes, gently lift the upper slide and measure the spread area.
5.3 Calculating Spreadability
- Spreadability is calculated using the formula:
- S = M × L / T
- Where:
- S = Spreadability (g.cm/sec)
- M = Weight applied (g)
- L = Length of the ointment spread (cm)
- T = Time required for spreading (sec)
- Compare the results against the predetermined spreadability specification.
5.4 Acceptance Criteria
- The spreadability should be within the predefined range for the specific ointment formulation.
- Significant deviations from the standard range may indicate formulation issues requiring further evaluation.
5.5 Documentation
- Record all measurements, weights applied, and results in the Spreadability Test Log.
- Document observations such as consistency, smoothness, and ease of application.
- QA personnel must review and approve results before batch release.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- R&D – Research and Development
7. Documents
- Spreadability Test Log (Annexure-1)
- Ointment Batch Testing Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- USP <1174> – Semisolid Drug Products
- ICH Q2 (R1) – Validation of Analytical Procedures
9. SOP Version
Version 2.0
10. Approval Section
|
Prepared By |
Checked By |
Approved By |
| Signature |
|
|
|
| Date |
|
|
|
| Name |
|
|
|
| Designation |
|
|
|
| Department |
|
|
|
11. Annexures
Annexure-1: Spreadability Test Log
| Date |
Batch Number |
Sample Weight (g) |
Weight Applied (g) |
Spread Diameter (cm) |
Result |
Verified By |
| 01/02/2025 |
OINT-101 |
0.5 |
200 |
5.2 |
Pass |
QA Officer |
| 02/02/2025 |
OINT-102 |
0.5 |
200 |
4.8 |
Pass |
QA Officer |
Annexure-2: Ointment Batch Testing Report
| Date |
Batch Number |
Test Method |
Acceptance Criteria |
Result |
Final Status |
Approved By |
| 01/02/2025 |
OINT-101 |
Parallel Plate |
4.5 – 5.5 cm |
5.2 cm |
Approved |
QA Head |
| 02/02/2025 |
OINT-102 |
Glass Slide |
4.5 – 5.5 cm |
4.8 cm |
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 |