Procedure for Capsule Weight Variation Testing

1) Purpose

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

2) Scope

This SOP applies to all capsule 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 capsule samples for testing and maintaining process parameters.

4) Procedure

4.1 Sampling:
    4.1.1 Collect a representative sample of capsules from different locations within a batch according to the sampling plan.
    4.1.2 Ensure the sample size is adequate (e.g., 10 capsules) 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 capsule individually and record the weight.
    4.3.2 Calculate the average weight of the capsules.
    4.3.3 Determine the percentage deviation of each capsule’s weight from the average weight using the formula: Percentage Deviation = [(Individual Capsule Weight – Average Weight) / Average Weight] × 100.

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