internal specifications and regulatory requirements.

4. Accountability

The QC Manager is accountable for ensuring that homogeneity testing is performed in accordance with this SOP. The Production Supervisor is responsible for ensuring that the cream formulations are uniformly mixed during production. The QA Manager ensures that the test results are reviewed and approved in compliance with GMP and regulatory standards.

5. Procedure

5.1 Pre-Test Preparation

1. Ensure that the necessary equipment for testing homogeneity is available, including a calibrated laboratory balance, a mixing machine, and a sample collection kit.
2. Ensure that the batch record has been reviewed to confirm that all ingredients and formulation details are correct, and to identify the appropriate testing method for homogeneity.
3. Prepare the necessary calibration standards or reference materials if needed, and ensure that all equipment is in proper working condition before starting the production process.

5.2 Mixing Process

1. Ensure that the cream is mixed according to the established formulation procedures, with specific attention to achieving uniform distribution of all ingredients.
2. Monitor the mixing speed and time to ensure that it falls within the optimal range for achieving homogeneity. Typically, mixing should be conducted at a consistent speed for a specified time to ensure complete blending.
3. Ensure that all mixing equipment (e.g., planetary mixers, homogenizers) is calibrated and functioning properly before use.

5.3 Sampling for Homogeneity Testing

1. Collect representative samples from different areas of the batch, including the top, middle, and bottom sections, to ensure accurate representation of the entire batch.
2. Label each 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 using proper aseptic techniques to prevent contamination and preserve homogeneity.

5.4 Homogeneity Testing Procedure

1. Weigh each sample using a calibrated laboratory balance to ensure the correct quantity for testing.
2. Test the samples for uniformity of content, checking the concentration of active ingredients and excipients. This can be done using techniques such as HPLC, UV-Visible spectrophotometry, or other appropriate analytical methods.
3. Perform testing for each sample in triplicate to ensure consistency and reliability of the results.
4. Record the results of each test, including the measured concentration of each active ingredient and any deviations from the expected content, in the Homogeneity Testing Log (Annexure-1).

5.5 Interpretation of Results

1. Compare the results of the homogeneity tests with the established specifications for the batch. The concentration of the active ingredients and excipients should be within the specified range to ensure uniformity.
2. If the test results show that the sample is within the acceptable range, mark the test as “Pass” in the Homogeneity Testing Log (Annexure-1) and proceed with the next stage of production or release.
3. If the test results show that the sample is outside the acceptable range, mark the test as “Fail.” Investigate the cause of the variation, which may include improper mixing, incorrect formulation, or equipment malfunction.

5.6 Post-Test Activities

1. Record all test results, including batch number, sample ID, test date, and any corrective actions taken in the Homogeneity Testing Log (Annexure-1).
2. If the homogeneity test fails, initiate corrective actions such as adjusting the formulation, improving mixing techniques, or reprocessing the batch to ensure homogeneity. 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.

5.7 Documentation and Record-Keeping

1. Ensure that all homogeneity testing records are complete, accurate, and securely stored. This includes the Homogeneity 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
• HPLC: High-Performance Liquid Chromatography

7. Documents

1. Annexure-1: Homogeneity Testing Log
2. 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 Uniformity of Content and Mixing 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: Homogeneity Testing Log

Batch Number	Sample ID	Test Date	Active Ingredient Content (%)	Operator
12345	S-001	21/01/2026	98.5%	John Doe

Annexure-2: Deviation Log

Deviation Date	Batch Number	Deviation Description	Corrective Action Taken	Operator
21/01/2026	12345	Active ingredient content out of specification	Reformulated 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