Standard Operating Procedure for Conducting Spreadability Tests on Creams
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/130/2025 |
| Supersedes | SOP/CRM/130/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 21/01/2026 |
| Effective Date | 26/01/2026 |
| Review Date | 21/01/2027 |
1. Purpose
The purpose of this SOP is to define the procedure for conducting spreadability tests on cream formulations. Spreadability is a key quality attribute for creams, as it determines the ease with which the product can be applied on the skin. The test ensures that the cream formulation meets the desired spreadability characteristics and is suitable for its intended use.
2. Scope
This SOP applies to all cream formulations produced in the facility. It covers the spreadability testing procedure after the cream is formulated and before it is released for packaging and distribution.
3. Responsibilities
- Production Team: Responsible for providing representative samples of the cream formulations for spreadability testing at the appropriate stage of production.
- Quality Control (QC) Team: Responsible for performing the spreadability tests using the appropriate instruments and ensuring the results meet the specified product criteria.
- Quality Assurance (QA) Team: Responsible for reviewing the results of spreadability tests to ensure compliance with internal specifications and regulatory guidelines.
4. Accountability
The QC Manager is accountable for ensuring that spreadability testing is carried out accurately and in accordance with this SOP. The Production Supervisor is responsible for ensuring the correct samples are provided for testing. The QA Manager ensures that the results are reviewed and approved in compliance with GMP and regulatory standards.
5. Procedure
5.1 Pre-Test Preparation
- Ensure that all necessary equipment for spreadability testing is available, including the spreadability apparatus, balance, and test plates. Calibrate the spreadability apparatus as per the manufacturer’s instructions.
- Review the batch record to identify the appropriate sampling points for spreadability testing. The sample should be taken after the final formulation step but before packaging.
- Ensure that the laboratory environment is clean and free from contamination, and that the necessary materials, such as clean test plates and spatulas, are available for testing.
5.2 Sample Collection
- Collect a representative sample of the cream formulation. The sample should be homogeneous and free from air bubbles or contamination.
- Label the sample with the batch number, sampling date, and sampling point to ensure traceability during testing.
- Allow the sample to come to room temperature, if necessary, before testing to ensure consistent results.
5.3 Spreadability Testing Procedure
- For the spreadability test, use a standard spreadability apparatus that measures the force required to spread a fixed amount of cream on a test plate. Ensure the plate is clean and level before applying the sample.
- Weigh a fixed amount of cream (e.g., 1 gram) and place it on the center of the test plate.
- Using the spreadability apparatus, apply a consistent force to spread the cream evenly across the test plate.
- Record the force required to spread the cream and any other observations such as the ease of spreading and any resistance encountered.
- Alternatively, if using a manual spreadability test, use a spatula to spread the cream on a surface and measure the distance the cream spreads under a set pressure. Record the distance in millimeters and any other relevant observations.
5.4 Interpretation of Results
- Compare the recorded spreadability data with the defined product specifications, which may include the minimum and maximum acceptable force or distance for spreading.
- If the cream meets the spreadability specifications, mark the test result as “Pass” in the Spreadability Testing Log (Annexure-1).
- If the test results fall outside the acceptable range, mark the test as “Fail.” Investigate potential causes for the failure, such as formulation issues or improper mixing, and implement corrective actions as necessary.
5.5 Post-Test Activities
- Record all test results, including batch number, sample ID, force required to spread (or spread distance), and any corrective actions taken, in the Spreadability Testing Log (Annexure-1).
- Ensure that the records are reviewed by the QA team to verify compliance with internal specifications and regulatory requirements.
- If the test results indicate a failure, review the formulation and manufacturing process to determine the cause of the deviation. If necessary, adjust the formulation and re-test the sample until it meets the spreadability criteria.
5.6 Documentation and Record-Keeping
- Ensure that all spreadability testing records are complete, accurate, and securely stored. This includes the Spreadability Testing Log (Annexure-1) and the Deviation Log (Annexure-2) for failed tests.
- Retain all records for a minimum of two years or as required by regulatory guidelines.
- Ensure that records are reviewed by the Quality Assurance team to verify compliance with GMP standards and regulatory requirements.
6. Abbreviations
- GMP: Good Manufacturing Practices
- QC: Quality Control
- QA: Quality Assurance
- PPE: Personal Protective Equipment
7. Documents
- Annexure-1: Spreadability Testing Log
- Annexure-2: Deviation Log
8. References
- Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
- International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
- Pharmacopeial Monographs for Spreadability Testing
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 Testing Log
| Batch Number | Sample ID | Sampling Date | Force Required to Spread (g) | Operator |
|---|---|---|---|---|
| 12345 | S-001 | 21/01/2026 | 50 g | John Doe |
Annexure-2: Deviation Log
| Deviation Date | Batch Number | Deviation Description | Corrective Action Taken | Operator |
|---|---|---|---|---|
| 21/01/2026 | 12345 | High force required to spread | Adjusted formulation, re-tested | Jane Smith |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/03/2024 | 1.0 | Initial Version | New SOP Creation | QA Head |
| 01/03/2025 | 2.0 | Format Revision and Updates | Standardization of Document | QA Head |