Procedure for Capsule Content Uniformity Testing

1) Purpose

The purpose of this SOP is to outline the procedure for testing the content uniformity of capsules to ensure consistent distribution of active pharmaceutical ingredient (API) across all dosage units.

2) Scope

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

3) Responsibilities

Quality Control (QC) Department: Responsible for conducting content uniformity 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 Select a statistically valid number of capsules from the batch according to the sampling plan (e.g., 30 capsules).
    4.1.2 Ensure the capsules are randomly chosen to represent the entire batch.

4.2 Equipment Preparation:
    4.2.1 Set up the equipment for content uniformity testing (e.g., HPLC system) as per the manufacturer’s instructions.
    4.2.2 Ensure the equipment is calibrated and validated for the analysis.

4.3 Content Uniformity Testing Procedure:
    4.3.1 Remove the contents of each selected capsule and weigh the total amount of API.
    4.3.2 Prepare a composite sample by combining the contents of all selected capsules.
    4.3.3 Analyze the composite sample using an appropriate analytical method (e.g., HPLC) to determine the API content.
    4.3.4 Calculate the mean and relative standard deviation (RSD) of API content to assess uniformity.

4.4 Acceptance Criteria:
    4.4.1 The capsule batch is acceptable if the RSD of API content does not exceed the specified limit (e.g., 6.0%).

4.5 Documentation:
    4.5.1 Document all results, calculations, chromatograms, and sample preparation details in the Capsule Content Uniformity Test Record.
    4.5.2 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

Capsule Content Uniformity Test Record
Calibration Record for Analytical Equipment
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