Standard Operating Procedure for Tablet Friability Testing

Purpose

The purpose of this SOP is to provide detailed guidelines for conducting tablet friability testing in pharmaceutical manufacturing. Friability testing is a critical quality control parameter that assesses the ability of tablets to withstand abrasion and impacts during handling and transportation. This SOP ensures accurate and consistent friability test results, contributing to the assessment of tablet quality and compliance with regulatory standards.

Scope

This SOP applies to all personnel involved in performing tablet friability testing within the pharmaceutical company.

Responsibilities

• The Quality Assurance (QA) department is responsible for implementing and maintaining this SOP.
• The Production department is responsible for conducting the tablet friability testing.

Procedure

Preparation

• Ensure that the tablet friability tester is clean, calibrated, and in proper working condition before starting the testing process.
• Verify that all necessary accessories, such as friability drums and sample cups, are available and in good condition.
• Check that the tablet friability tester is connected to a stable power source and properly grounded.
• Review the product’s batch record or quality control specifications to determine the required number of tablets for testing.

Friability Testing

1. Weigh the specified number of tablets accurately, and place them into the friability drums.
2. Securely attach the friability drums to the tester, ensuring they are balanced and aligned properly.
3. Set the friability tester to the predetermined rotation speed and testing duration according to the product’s requirements.
4. Start the friability test, allowing the tablets to undergo the specified number of rotations.
5. After the test is completed, carefully remove the tablets from the friability drums, taking care not to damage or break them.
6. Weigh the tablets again after the test and calculate the percentage friability using the following formula:

   Friability (%) = [(Initial Weight - Final Weight) / Initial Weight] x 100

7. Record the friability test results accurately in the appropriate records or data sheets.

Post-Testing

• Review the friability test results and compare them with the predefined acceptance criteria specified in the product’s batch record or quality control specifications.
• Document the friability test results, including the date, test parameters, and results obtained.
• Take appropriate action for any tablets that do not meet the specified friability requirements, following the company’s standard operating procedures for out-of-specification results.
• Notify the relevant departments if there are any quality issues or deviations found during the friability testing process.

Abbreviations

• QA: Quality Assurance
• SOP: Standard Operating Procedure

Documents

• Tablet Friability Test Results Log

References

No specific references are applicable for this SOP.

SOP Version

This is version 1.0 of the SOP for Tablet Friability Testing.