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 the average weight by more than the specified percentage (e.g., ±5%).
4.5 Documentation:
4.5.1 Document all weights and calculations in the Capsule 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
Capsule Weight Variation Test Record
Calibration Record for Analytical Balance
Sampling Plan Document
7) Reference, if any
USP <905> – Uniformity of Dosage Units (Capsules)
21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
8) SOP Version
Version 1.0
