Procedure for Measuring Tablet Thickness

1) Purpose

The purpose of this SOP is to outline the procedure for measuring the thickness of tablets to ensure uniformity and compliance with specified dimensions.

2) Scope

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

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting thickness measurements 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., 10 tablets) to obtain a uniform representation.

4.2 Equipment Preparation:
    4.2.1 Calibrate the thickness gauge or micrometer as per the manufacturer’s instructions.
    4.2.2 Ensure the gauge is clean and free from previous residues.

4.3 Thickness Measurement Procedure:
    4.3.1 Place a tablet between the jaws of the thickness gauge or micrometer.
    4.3.2 Close the jaws gently until they touch the tablet, ensuring not to compress it.
    4.3.3 Record the thickness reading.
    4.3.4 Repeat the process for all tablets in the sample.

4.4 Calculation:
    4.4.1 Calculate the average thickness of the tablets.
    4.4.2 Determine the standard deviation to assess the consistency of tablet thickness.

4.5