Standard Operating Procedure for Friability Testing of Tablets

1) Purpose

This SOP outlines the procedures for conducting friability testing on pharmaceutical tablets to assess their resistance to abrasion and impact.

2) Scope

This SOP applies to friability testing of tablets manufactured in the pharmaceutical facility.

3) Responsibilities

The Quality Control (QC) department is responsible for performing friability testing. Production personnel are responsible for sample preparation. Quality Assurance (QA) oversees the process and ensures compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Preparation

1. Review the friability testing protocol and ensure all necessary materials and equipment are available (e.g., friability tester).
2. Verify the calibration and functionality of the friability tester.

4.2 Sample Collection and Preparation

1. Collect a representative sample of tablets according to sampling procedures.
2. Ensure proper labeling and identification of samples.

4.3 Testing Procedure

1. Weigh the tablets and place them in the friability tester.
2. Operate the friability tester under specified conditions (e.g., number of rotations, duration).
3. After testing, remove the tablets, brush off any loose dust, and reweigh.
4. Calculate the percentage friability using the formula:
   ( text{Friability (%)} = left( frac{{text{Initial weight – Final weight}}}{{text{Initial weight}}} right) times 100 )

4.4 Acceptance Criteria

1. Ensure that the percentage friability of the tested tablets