SOP Guide for Pharma

Tablets: SOP for In-Process Uniformity of Blend Testing – V 2.0

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Tablets: SOP for In-Process Uniformity of Blend Testing – V 2.0

Standard Operating Procedure for In-Process Uniformity of Blend Testing

Department Tablet
SOP No. SOP/TAB/158/2025
Supersedes SOP/TAB/158/2022
Page No. Page 1 of 6
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

To define the procedure for conducting in-process testing of blend uniformity during tablet manufacturing to ensure that the mixture of ingredients is consistent and within the specified quality standards.

2. Scope

This SOP applies to the testing of blend uniformity during the tablet manufacturing process, ensuring uniform distribution of active pharmaceutical ingredients (APIs) and excipients throughout the blend.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring that the blend uniformity testing is conducted regularly during the manufacturing process. The QA Manager ensures the procedure is followed and results are documented appropriately.

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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.
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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.
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6. Abbreviations

7. Documents

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

8. References

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
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