Procedure for Evaluating Physical Properties of Ointment Samples
| Department | Research and Development (R&D)/Quality Control |
|---|---|
| SOP No. | FD-013 |
| 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 outline the procedure for evaluating the physical properties of ointment samples. This ensures product consistency, quality, and compliance with established specifications before further development or market release.
2. Scope
This SOP applies to all ointment samples prepared during research, development, and manufacturing. It covers tests for physical appearance, viscosity, spreadability, homogeneity, pH, and stability.
3. Responsibilities
- Formulation Scientist: Prepares and submits samples for physical evaluation.
- Quality Control (QC) Analyst: Conducts the tests and records observations.
- Quality Assurance (QA) Personnel: Verifies compliance with the required specifications.
- R&D Head: Reviews the evaluation data and approves further testing or modifications.
4. Accountability
The R&D and QC Managers are accountable for ensuring that all physical property evaluations are conducted according to this SOP and documented properly.
5. Procedure
5.1 Sample Preparation
- Ensure that ointment samples are collected in clean, labeled containers.
- Prepare at least three replicate samples to ensure test reproducibility.
- Store samples under recommended temperature and humidity conditions before testing.
5.2 Physical Appearance
- Visually inspect the sample for color, texture, and phase separation.
- Record any visible defects such as air bubbles, crystallization, or contamination.
5.3 Viscosity Measurement
- Use a Brookfield Viscometer or equivalent to measure viscosity.
- Ensure that the instrument is calibrated before measurement.
- Record the viscosity in centipoise (cP) and compare it with standard specifications.
5.4 Spreadability Test
- Place 1 g of ointment between two glass slides.
- Apply a standard weight and measure the diameter of the spread sample.
- Record the spreadability index in mm.
5.5 Homogeneity Assessment
- Take a small quantity of ointment on a glass plate.
- Spread it uniformly and observe under a magnifying lens.
- Ensure that there are no lumps, particles, or phase separation.
5.6 pH Measurement
- Dissolve 1 g of ointment in 10 mL of distilled water.
- Measure the pH using a calibrated pH meter.
- Ensure that the pH falls within the specified range (e.g., 5.0-7.5).
5.7 Stability Testing
- Store samples at different conditions:
- 25°C ± 2°C / 60% RH
- 40°C ± 2°C / 75% RH
- Refrigerated conditions (2-8°C)
- Observe any changes in color, texture, or phase separation over time.
- Record and compare the results with initial observations.
5.8 Documentation and Reporting
- Record all test results in the Ointment Evaluation Log.
- Summarize the findings in an Evaluation Report.
- QA personnel must verify and approve results before further testing or product modifications.
6. Abbreviations
- QC – Quality Control
- QA – Quality Assurance
- R&D – Research and Development
- RH – Relative Humidity
- cP – Centipoise
7. Documents
- Ointment Evaluation Log (Annexure-1)
- Evaluation Report (Annexure-2)
8. References
- ICH Q1A (R2) Stability Testing Guidelines
- USP <911> Viscosity Guidelines
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Ointment Evaluation Log
| Date | Batch Number | Test Parameter | Specification | Result | Verified By |
|---|---|---|---|---|---|
| 01/02/2025 | OINT-001 | Viscosity | 1000-2000 cP | 1500 cP | QA Officer |
| 02/02/2025 | OINT-002 | pH | 5.5-7.5 | 6.2 | QA Officer |
Annexure-2: Evaluation Report
| Date | Batch Number | Appearance | Spreadability | Stability Observation | Final Status |
|---|---|---|---|---|---|
| 01/02/2025 | OINT-001 | White, smooth | 5 mm | No changes | Pass |
| 02/02/2025 | OINT-002 | Yellowish, grainy | 3 mm | Separation observed | Fail |
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 |