Procedure for Tablet Weight Variation Testing

1) Purpose

The purpose of this SOP is to outline the procedure for determining the weight variation of tablets to ensure uniformity and compliance with pharmacopeial standards.

2) Scope

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

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting weight variation 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 analytical balance as per the manufacturer’s instructions.
    4.2.2 Ensure the balance is clean and free from previous residues.

4.3 Weight Variation Determination:
    4.3.1 Weigh each tablet individually and record the weight.
    4.3.2 Calculate the average weight of the tablets.
    4.3.3 Determine the percentage deviation of each tablet’s weight from the average weight using the formula: Percentage Deviation = [(Individual Tablet Weight – Average Weight) / Average Weight] × 100.

4.4 Acceptance Criteria:
    4.4.1 The tablet batch is acceptable if no more than two tablets deviate from