Procedure for Uniformity of Dosage Units Testing
1) Purpose
The purpose of this SOP is to outline the procedure for testing the uniformity of dosage units (tablets) to ensure consistent distribution of the active pharmaceutical ingredient (API) among individual units.
2) Scope
This SOP applies to all batches of tablets produced within the manufacturing facility.
3) Responsibilities
Quality Control (QC) Department: Responsible for conducting uniformity 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 Select a statistically valid number of tablets from the batch according to the sampling plan (e.g., 30 tablets).
4.1.2 Ensure the tablets are randomly chosen to represent the entire batch.
4.2 Equipment Preparation:
4.2.1 Set up the apparatus for uniformity testing (e.g., analytical balance) as per the manufacturer’s instructions.
4.2.2 Ensure the equipment is calibrated and validated for the analysis.
4.3 Weight Variation Testing Procedure:
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 Content Uniformity Testing Procedure:
4.4.1 Select a subset of tablets from the sample.
4.4.2 Remove the contents of each tablet and weigh the amount of API.
4.4.3 Prepare a composite sample by combining the contents of all selected tablets.
4.4.4 Analyze the composite sample using an appropriate analytical method (e.g., HPLC) to determine the API content.
4.4.5 Calculate the mean and relative standard deviation (RSD) of API content to assess uniformity.
4.5 Acceptance Criteria:
4.5.1 Weight Variation: 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%).
4.5.2 Content Uniformity: The tablet batch is acceptable if the RSD of API content does not exceed the specified limit (e.g., 6.0%).
4.6 Documentation:
4.6.1 Document all results, calculations, and observations in the Tablet Uniformity Test Record.
4.6.2 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
API: Active Pharmaceutical Ingredient
HPLC: High-Performance Liquid Chromatography
RSD: Relative Standard Deviation
6) Documents, if any
Tablet Uniformity Test Record
Calibration Record for Analytical Equipment
Sampling Plan Document
7) Reference, if any
USP <905> – Uniformity of Dosage Units (Tablets)
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0