Procedure for Tablet Friability Testing

1) Purpose

The purpose of this SOP is to outline the procedure for determining the friability of tablets to ensure they have adequate mechanical strength to withstand handling and transportation.

2) Scope

This SOP applies to all tablet batches produced within the manufacturing facility.

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting friability testing and ensuring compliance with this SOP.
Production Department: Responsible for providing tablet samples for testing and maintaining process parameters.

4) Procedure

4.1 Sampling:
    4.1.1 Collect a representative sample of tablets from different locations within a batch according to the sampling plan.
    4.1.2 Ensure the sample size is adequate (e.g., 20 tablets) to obtain a uniform representation.

4.2 Equipment Preparation:
    4.2.1 Calibrate the friability tester as per the manufacturer’s instructions.
    4.2.2 Ensure the tester is clean and free from previous residues.

4.3 Friability Testing Procedure:
    4.3.1 Weigh the sample of tablets and record the initial weight.
    4.3.2 Place the tablets in the drum of the friability tester.
    4.3.3 Operate the tester for a specified number of rotations (e.g., 100 rotations at 25 rpm).
    4.3.4 After testing, remove the tablets and brush off any dust.
    4.3.5 Weigh the tablets again and record the final weight.

4.4 Calculation:
    4.4.1 Calculate