SOP Guide for Pharma

Tablets: SOP for Blend Uniformity Testing for Granules – V 2.0

Auditor

Tablets: SOP for Blend Uniformity Testing for Granules – V 2.0

Standard Operating Procedure for Blend Uniformity Testing for Granules

Department Tablet
SOP No. SOP/TAB/089/2025
Supersedes SOP/TAB/089/2022
Page No. Page 1 of 6
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

To establish the procedure for blend uniformity testing of granules, ensuring that the active pharmaceutical ingredient (API) and excipients are evenly distributed within the blend, achieving consistent product quality and regulatory compliance.

2. Scope

This SOP applies to the blend uniformity testing of granules used in tablet formulations to ensure uniform distribution of the API and excipients before tablet compression.

3. Responsibilities

4. Accountability

The QC Manager is accountable for ensuring the blend uniformity testing is conducted in compliance with this SOP. The QA Manager is responsible for reviewing the results and approving the batch for release.

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5. Procedure

5.1 Sample Collection

  1. Collect a representative sample of the granules from the batch, as specified in the batch record.
  2. The sample should consist of a minimum of 6 portions from different points in the blend (e.g., top, middle, bottom, and several intermediate points).
  3. Ensure that the granules are free from contamination or defects.
  4. Label the sample portions appropriately for identification during testing.

5.2 Preparation of Testing Apparatus

  1. Ensure that all required equipment (e.g., analytical balance, sieve, sample containers) is clean and calibrated according to company SOPs.
  2. Prepare the apparatus for testing according to the method specified in the pharmacopeial guidelines or batch record.

5.3 Performing the Blend Uniformity Test

  1. Weigh each of the sample portions using a calibrated analytical balance. Record the weight of each portion in the batch record (Annexure-1).
  2. Mix the granules as specified (e.g., using a laboratory-scale blender) to ensure uniformity in the sample before testing.
  3. Homogenize the samples to ensure consistency in the distribution of the API and excipients throughout the batch.
  4. If testing by sample weight variation method, ensure that the sample weight is within the specified limits for uniformity as outlined in the pharmacopeia or batch record.
  5. Alternatively, if using content uniformity method, dissolve the sample in an appropriate solvent and perform the assay for the API content.
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5.4 Data Recording and Calculation

  1. Record the weight of each portion or the assay result in the batch record (Annexure-1).
  2. Calculate the % Relative Standard Deviation (RSD) for the sample weights or API content, as per the following formula:
    • RSD (%) = (Standard Deviation / Mean) × 100
  3. Ensure that the RSD is within the acceptable range specified in the batch record or pharmacopeial guidelines (usually ≤ 5% for granules).

5.5 Acceptance Criteria

  1. Ensure that the blend uniformity test results meet the acceptance criteria, including the acceptable % RSD and API content uniformity.
  2. If the results fall outside the specified limits, investigate the cause and document the findings in the deviation report (Annexure-2).
  3. Implement corrective actions as needed to address any issues with blend uniformity.

5.6 Documentation and Record-Keeping

  1. Document all test results, including individual sample weights or assay results, calculations, and observations in the batch record (Annexure-1).
  2. Record any deviations from the acceptance criteria in the deviation report (Annexure-2), along with corrective actions taken.
  3. Ensure all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.

5.7 Post-Test Cleanup

  1. Clean all equipment used for blend uniformity testing, including sample containers and balances, according to the cleaning SOP to prevent contamination between tests.
  2. Ensure that the laboratory equipment is properly stored and maintained in good working condition.
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6. Abbreviations

7. Documents

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

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: Batch Record

Batch Number Sample Name Sample Weight (g) Assay Result (%) RSD (%) Result
Batch 001 Granules 10.00 99.8 2.5 Pass

Annexure-2: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
15/12/2025 Batch 001 RSD exceeded specification Reworked blending process Jane Doe

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 Testing Parameters Refined blend uniformity protocols QA Head
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