Manager is accountable for ensuring that color consistency testing is performed according to this SOP. The Production Supervisor is responsible for ensuring that the cream formulations meet the specified color requirements. The QA Manager ensures that the test results comply with GMP and regulatory standards.

5. Procedure

5.1 Pre-Test Preparation

1. Ensure that the necessary equipment for color consistency testing is available, including a spectrophotometer, colorimeter, or other suitable devices for measuring color.
2. Calibrate the color measurement equipment according to the manufacturer’s instructions to ensure accurate color readings.
3. Review the batch record to confirm the color specifications for the cream formulation being tested.

5.2 Sample Collection

1. Collect a representative sample of the finished cream formulation for color consistency testing. Ensure that the sample is homogenous and free from contamination.
2. Label the sample with the batch number, sample ID, sampling date, and other relevant details to ensure traceability during testing.
3. Ensure that the sample is taken from fully formulated and sealed cream products, which are ready for packaging.

5.3 Color Consistency Testing Procedure

1. Use a colorimeter or spectrophotometer to measure the color of the cream sample. The color should be measured using standardized color spaces, such as CIE L*a*b* or RGB.
2. Take at least three measurements from different spots on the surface of the cream to ensure representative sampling. The sample should be measured in a controlled environment with proper lighting conditions (e.g., D65 light source).
3. Record the color values obtained from the instrument, including L* (lightness), a* (red-green axis), and b* (yellow-blue axis) for CIE L*a*b* color space, or the relevant values for other systems.
4. Compare the recorded values with the established color specifications for the formulation. Color consistency is considered acceptable if the values are within the allowable variation range defined in the specification.
5. Record the results of each test in the Color Consistency Testing Log (Annexure-1).

5.4 Interpretation of Results

1. Compare the color measurement values with the predefined color specification limits. The acceptable variation should be predefined in terms of Delta E (ΔE), where a variation less than 2 ΔE is typically considered acceptable.
2. If the measured color is within the specified range, mark the test as “Pass” in the Color Consistency Testing Log (Annexure-1) and proceed with the next stage of production or release.
3. If the measured color is outside the acceptable range, mark the test as “Fail.” Investigate the cause of the deviation, which may include formulation issues, equipment calibration problems, or improper mixing.

5.5 Post-Test Activities

1. Record all test results, including batch number, sample ID, color values, and any corrective actions taken, in the Color Consistency Testing Log (Annexure-1).
2. If the color consistency test fails, initiate corrective actions, such as adjusting the formulation, re-calibrating the equipment, or improving the mixing process. Re-test the sample after corrective actions.
3. Submit the test results for review and approval by the QA team to ensure compliance with internal and regulatory standards.

5.6 Documentation and Record-Keeping

1. Ensure that all color consistency testing records are complete, accurate, and securely stored. This includes the Color Consistency Testing Log (Annexure-1) and the Deviation Log (Annexure-2) for failed tests.
2. Retain all records for a minimum of two years or as required by regulatory guidelines.
3. 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
• ΔE: Color Difference
• CIE: Commission Internationale de l’Éclairage

7. Documents

1. Annexure-1: Color Consistency Testing Log
2. Annexure-2: Deviation Log

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• ISO 13485:2016 – Quality Management Systems for Medical Devices (for cosmetic products, similar standards apply)
• Colorimetry: Understanding the CIE System – ASTM E308-16

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Color Consistency Testing Log

Batch Number	Sample ID	Test Date	Color Values (L*a*b*)	Operator
12345	S-001	21/01/2026	80.1, -1.2, 10.5	John Doe

Annexure-2: Deviation Log

Deviation Date	Batch Number	Deviation Description	Corrective Action Taken	Operator
21/01/2026	12345	Color deviation above acceptable range	Adjusted formulation and 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