SOP Guide for Pharma

Tablets: SOP for End-Point Determination in Wet Granulation – V 2.0

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Tablets: SOP for End-Point Determination in Wet Granulation – V 2.0

Standard Operating Procedure for End-Point Determination in Wet Granulation

Department Tablet
SOP No. SOP/TAB/135/2025
Supersedes SOP/TAB/135/2022
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 determining the end-point in the wet granulation process to ensure that the granules achieve the desired properties such as adequate size, uniformity, and moisture content before moving to the next stage of tablet manufacturing.

2. Scope

This SOP applies to the wet granulation process for tablet manufacturing. It ensures that the granulation is complete, with granules having the correct properties before proceeding to drying and subsequent tablet compression.

3. Responsibilities

4. Accountability

The Granulation Supervisor is accountable for ensuring that the end-point determination procedure is properly followed during the wet granulation process. The QC Manager is responsible for reviewing and ensuring the accuracy of the test results.

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5. Procedure

5.1 Moisture Content Testing

  1. After the granulation process, take a sample of the wet granules for moisture content testing. Ensure that the sample represents the entire batch by collecting from different locations (top, middle, and bottom of the batch).
  2. Weigh the sample and record the weight.
  3. Place the sample in a drying oven or use a moisture analyzer to determine the moisture content. Typically, the granules should contain between 3% and 7% moisture, depending on the formulation requirements.
  4. If the moisture content is within the acceptable range, proceed to the drying process. If the moisture content is too high, continue granulating or adjust the binder addition accordingly.

5.2 Granule Size and Appearance Evaluation

  1. Inspect the granules for uniformity in size and appearance. Use a sieve to measure the granule size distribution, ensuring that the granules are within the specified size range.
  2. Granules should not be too fine or too coarse, as this will affect the tablet compression and dissolution characteristics.
  3. Granules should be spherical or near-spherical in shape, free of excessive dust or clumping, to ensure good flowability during the compression process.
  4. If the granule size is outside the acceptable range, adjust the granulation process (e.g., binder solution concentration, granulation time) and re-sample until the desired granule properties are achieved.

5.3 End-Point Determination Tests

  1. Once the granules meet the required moisture content and size specifications, perform an end-point test using a granulation consistency check, such as a “hand test” or “snap test.”
  2. For the hand test, take a small portion of the granules and attempt to form a dough-like consistency by applying slight pressure. The granules should form a cohesive mass without excessive breakage.
  3. For the snap test, place a small amount of granules into the granulator and check if the granules snap back into the drum when the mixer is stopped, indicating proper consistency.
  4. Record the results and confirm that the granules meet the established end-point criteria before proceeding to the drying stage.
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5.4 Monitoring and Adjustments

  1. If the granules do not meet the required moisture content, size distribution, or consistency, adjust the granulation process accordingly by modifying the binder, wetting solution, or granulation time.
  2. Once adjustments are made, repeat the end-point determination tests to confirm that the granulation process is complete.

5.5 Documentation

  1. Document the moisture content, granule size, and appearance test results in the batch record (Annexure-2), including any deviations or corrective actions taken.
  2. Record the results of the hand and snap tests in the batch record and ensure that they meet the established criteria for end-point determination.
  3. Ensure that all records are signed, dated, and reviewed by QA to verify compliance with quality standards.

5.6 Acceptance Criteria

  1. The moisture content of the granules should be within the specified range (usually between 3% and 7%).
  2. The granule size should meet the required specifications, typically between 40 and 80 mesh, with no excessive fines or large agglomerates.
  3. The granules should demonstrate proper cohesion and flowability based on the hand and snap tests.
  4. If the granules do not meet the acceptance criteria, the batch may need to be rejected or reworked.
See also  Tablets: SOP for End-Point Determination in Granulation Process - V 2.0

5.7 Post-Granulation Actions

  1. Once the end-point has been confirmed, proceed with the drying process to reduce the moisture content to the desired level for tablet compression.
  2. Ensure that the granulation equipment is cleaned and maintained according to the preventive maintenance schedule after each use.

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 Moisture content outside specified range Increased binder concentration and re-sampled John Doe

Annexure-2: Batch Record

Sample Number Moisture Content Granule Size Action Taken
Sample 1 5.0% 40 mesh Accepted

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 granulation process and testing method Improved process monitoring QA Head
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