Standard Operating Procedure for Testing Creams for UV Protection Properties
| Department | Creams |
|---|---|
| SOP No. | SOP/CRM/150/2025 |
| Supersedes | SOP/CRM/150/2022 |
| 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 testing the UV protection properties of cream formulations. UV protection is an essential attribute for sunscreens and other creams that are designed to protect the skin from harmful ultraviolet (UV) radiation. This SOP ensures that the cream formulations meet the required UV protection standards.
2. Scope
This SOP applies to all cream formulations manufactured at the facility that are intended for UV protection, including sunscreens and other topical products. It covers the procedures for testing the SPF (Sun Protection Factor) and UVA/UVB protection levels of the creams under controlled conditions.
3. Responsibilities
- Production Team: Responsible for ensuring the preparation of cream samples according to the formulation and packaging requirements for UV protection testing.
- Quality Control (QC) Team: Responsible for conducting the UV protection testing of the cream samples, including testing for SPF and UVA/UVB protection levels.
- Quality Assurance (QA) Team: Responsible for reviewing the test results, ensuring compliance with internal and regulatory standards, and approving the results for release.
4. Accountability
The QC Manager is accountable for ensuring that UV protection testing is conducted in accordance with this SOP. The Production Supervisor is responsible for ensuring that the correct samples are prepared for UV protection testing. The QA Manager ensures that the test results are reviewed and comply with regulatory and internal standards.
5. Procedure
5.1 Pre-Test Preparation
- Ensure that all necessary testing equipment is available and calibrated, including UV spectrophotometers, solar simulators, and irradiation chambers.
- Review the batch record to confirm the formulation details, ensuring that the cream is intended for UV protection and that it meets the necessary specifications.
- Prepare the cream samples for testing according to the formulation and ensure they are properly homogenized and free from contamination.
- Label each sample with the batch number, sample ID, and testing start date to ensure proper traceability during testing.
5.2 Testing Procedure for SPF (Sun Protection Factor)
- Apply the cream samples to the surface of an artificial skin model or a human test panel. The amount of cream applied should be consistent for all samples.
- Expose the sample to controlled UV light using a solar simulator with known UVA and UVB output to simulate sunlight exposure.
- After a specified period (e.g., 15 to 30 minutes), measure the erythema (skin redness) induced by the UV exposure using a standardized method, such as the Minimal Erythemal Dose (MED) test.
- Calculate the SPF by comparing the amount of UV radiation required to induce erythema with and without the product applied. Use the following formula for SPF calculation:
- SPF = (MED with sunscreen) / (MED without sunscreen)
- Record the SPF value and the testing date in the UV Protection Testing Log (Annexure-1).
5.3 Testing Procedure for UVA/UVB Protection
- In addition to SPF testing, assess the UVA/UVB protection properties of the cream using a standardized in-vitro method, such as the UVA Protection Factor (UVA-PF) test or by using the Broad Spectrum Protection method.
- Expose the cream samples to UV light and measure the absorbance or transmission spectra to determine the cream’s ability to block both UVA and UVB radiation.
- Record the UVA/UVB protection results in the UV Protection Testing Log (Annexure-1).
5.4 Post-Test Activities
- Analyze the results to determine if the cream meets the required SPF and UVA/UVB protection standards. Compare the obtained values with the regulatory requirements and internal specifications.
- If the test results meet the specifications, mark the test as “Pass” and proceed with the product release or further processing.
- If the test results fail to meet the specifications, mark the test as “Fail.” Investigate potential causes of failure, such as incorrect formulation, improper application, or equipment malfunction, and take corrective actions as necessary.
5.5 Documentation and Record-Keeping
- Ensure that all testing records are complete, accurate, and securely stored. This includes the UV Protection Testing Log (Annexure-1) and any Deviation Logs (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 and approved 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: UV Protection 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 on Sunscreen Products
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: UV Protection Testing Log
| Batch Number | Sample ID | Test Date | SPF | UVA Protection Factor | UVB Protection Factor | Operator |
|---|---|---|---|---|---|---|
| 12345 | S-001 | 21/01/2026 | SPF 30 | UVA-PF 20 | UVB-PF 15 | John Doe |
Annexure-2: Deviation Log
| Deviation Date | Batch Number | Deviation Description | Corrective Action Taken | Operator |
|---|---|---|---|---|
| 21/01/2026 | 12345 | SPF below specification | Reformulated the batch and adjusted the SPF levels | 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 |