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 the average weight by more than the specified percentage (e.g., ±5% for tablets weighing 130-324 mg, ±7.5% for tablets weighing 80-130 mg, and ±10% for tablets weighing less than 80 mg).
4.5 Documentation:
4.5.1 Document all weights and calculations in the Tablet Weight Variation Test Record.
4.5.2 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
6) Documents, if any
Tablet Weight Variation Test Record
Calibration Record for Analytical Balance
Sampling Plan Document
7) Reference, if any
USP <905> – Uniformity of Dosage Units
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0