Tablets: SOP for Friability Testing for Sugar-Coated Tablets – V 2.0

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Tablets: SOP for Friability Testing for Sugar-Coated Tablets – V 2.0

Standard Operating Procedure for Friability Testing for Sugar-Coated Tablets

Department Tablet
SOP No. SOP/TAB/073/2025
Supersedes SOP/TAB/073/2022
Page No. Page 1 of 6
Issue Date 15/02/2026
Effective Date 20/02/2026
Review Date 15/02/2027

1. Purpose

To provide the procedure for conducting friability testing on sugar-coated tablets to ensure that they meet the required mechanical strength and durability criteria.

2. Scope

This SOP applies to the friability testing of sugar-coated tablets to evaluate their ability to withstand mechanical stress during handling and packaging.

3. Responsibilities

  • Manufacturing Personnel: Responsible for providing samples of sugar-coated tablets for friability testing.
  • Quality Control (QC): Responsible for performing the friability test, recording the results, and ensuring the tablets meet the specified friability limits.
  • Quality Assurance (QA): Ensures that the testing is performed according to this SOP and reviews the test results for batch release.

4. Accountability

The QC Manager is accountable for ensuring that the friability test is conducted according to this SOP and for reporting the results. The QA Manager is responsible for reviewing the results and approving the batch for release.

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5. Procedure

5.1 Sample Preparation

  1. Collect a representative sample of sugar-coated tablets from the batch. A typical sample should consist of 10 tablets, but this may vary depending on the batch size.
  2. Ensure that the sample is free from any visible defects such as cracks or chips.
  3. Label the sample appropriately and store it in conditions suitable for testing.

5.2 Friability Test Setup

  1. Ensure the friabilator is clean, calibrated, and functioning correctly according to the manufacturer’s instructions.
  2. Set the friabilator to the correct speed (typically 25 rpm) and time (usually 4 minutes), ensuring that the equipment is ready for testing.
  3. Weigh the initial sample of 10 tablets and record their total weight in the batch record (Annexure-1).

5.3 Conducting the Friability Test

  1. Place the 10 sugar-coated tablets in the friabilator drum.
  2. Activate the friabilator and allow the tablets to rotate for 100 revolutions (approximately 4 minutes).
  3. After the specified time, remove the tablets from the friabilator and weigh them again, recording the final weight in the batch record (Annexure-1).
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5.4 Calculate the Friability

  1. Calculate the percentage of weight loss using the following formula:

    2. Friability (%) = (Initial weight – Final weight) / Initial weight x 100

  2. Ensure that the friability of the tablets is within the acceptable limits, typically less than 1% weight loss, but this may vary depending on the product specifications.
  3. Record the friability result in the batch record (Annexure-1). If the weight loss exceeds the specified limits, document the findings in the deviation report (Annexure-2).

5.5 Documentation and Record-Keeping

  1. Document all results of the friability test, including the initial and final weights of the tablets and the calculated friability percentage, in the batch record (Annexure-1).
  2. Record any deviations from the established friability limits in the deviation report (Annexure-2), along with corrective actions taken.
  3. Ensure that all records are signed, dated, and retained according to the company’s record retention policy for future audits and inspections.

5.6 Post-Test Cleanup

  1. Clean the friabilator after each test according to the manufacturer’s guidelines and the company’s cleaning SOP.
  2. Ensure that all glassware and equipment used during the friability testing are thoroughly cleaned and stored appropriately.

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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • API: Active Pharmaceutical Ingredient

7. Documents

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

8. References

  • USP <1216> – Friability Test
  • 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
  • EU GMP Guidelines Part I – Basic Requirements for Medicinal Products

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 Tablet Sample Initial Weight (g) Final Weight (g) Friability (%)
Batch 001 10 tablets 10.50 g 10.45 g 0.48%

Annexure-2: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
12/12/2025 Batch 001 Friability > 1% Reformulated coating composition 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 Testing Parameters Improved Testing Method QA Head
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