procedure is followed and results are documented appropriately.

5. Procedure

5.1 Preparation for Testing

1. Verify that the blending equipment has been cleaned and calibrated according to the SOP for equipment qualification.
2. Ensure that the batch of materials is ready for blending, including proper mixing of active ingredients and excipients.
3. Prepare the required testing equipment, including sampling tools, scales, and containers for blend sampling.
4. Confirm that the blend is prepared in accordance with the batch record and formulation requirements.

5.2 Sampling of the Blend

1. Take a sample of the blend from different points within the blending equipment to ensure that the sample is representative of the entire batch.
2. Follow the sampling plan for the number of samples to be taken and the locations from which the samples should be collected.
3. Ensure that the samples are properly labeled with batch information and time of sampling to ensure traceability.

5.3 Blend Uniformity Testing

1. Weigh each sample of the blend and test for uniformity using a method approved by the QC department (e.g., content uniformity or weight variation test).
2. For content uniformity testing, check the active ingredient concentration in the sample to ensure it is within the specified range.
3. If the testing method is weight variation, ensure that each sample meets the predetermined weight variation criteria specified in the batch record.
4. If an automated system is used for testing, ensure the system is calibrated and functioning properly before testing the samples.

5.4 Documentation of Results

1. Record the results of the blend uniformity testing in the batch record (Annexure-2), including the test method used, the results for each sample, and any deviations from the specification.
2. For failed tests, initiate a deviation report (Annexure-1) and document the cause of the failure and any corrective actions taken.
3. Ensure that the documentation includes relevant details such as sample locations, batch number, test conditions, and any corrective measures taken.

5.5 Corrective Actions for Blend Uniformity Issues

1. If the blend uniformity test results do not meet the specifications, investigate the cause. Potential causes could include inadequate mixing, equipment malfunction, or incorrect formulation.
2. Adjust the blending process as needed, including adjusting mixing time, speed, or batch size, and re-sample the blend for further testing.
3. If the issue persists, consider reworking the batch or investigating other potential causes, such as raw material quality issues.
4. Ensure that all corrective actions are documented and reviewed by the QA team for approval.

5.6 Acceptance Criteria

1. The blend is considered acceptable if the test results fall within the established limits for uniformity, as defined in the batch record and specifications.
2. If more than a specified percentage (e.g., 2%) of the samples fail to meet the uniformity specifications, initiate a full investigation and corrective actions.

5.7 Post-Testing Actions

1. If the blend is acceptable, proceed with the next step in the tablet manufacturing process, such as tablet compression or coating.
2. If the blend is rejected, review the blending process, investigate the root cause, and take corrective actions as necessary. Re-sample and retest the blend before proceeding with tablet manufacturing.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• CAPA: Corrective and Preventive Action

7. Documents

1. Batch Record (Annexure-2)
2. Deviation Report (Annexure-1)

8. References

• USP <701> – Uniformity of Dosage Units
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• European Pharmacopoeia (EP) – Guidelines for Tablet Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	Blend uniformity failed the content uniformity test	Adjusted mixing time and reworked batch	John Doe

Annexure-2: Batch Record

Sample Number	Blend Uniformity Test Result	Moisture Content	Tested By
Sample 1	Pass	3.2%	Jane Smith

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated sampling and testing procedures	Improved uniformity testing accuracy	QA Head