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
4.5.1 The tablet batch is acceptable if the thickness falls within the specified range (e.g., ±0.1 mm of the target thickness).
4.6 Documentation:
4.6.1 Document all results and calculations in the Tablet Thickness Measurement Record.
4.6.2 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Tablet Thickness Measurement Record
Calibration Record for Thickness Gauge
Sampling Plan Document
7) Reference, if any
USP <1217> – Tablet Thickness
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0
