Procedure for Content Uniformity in Capsules
1) Purpose
The purpose of this SOP is to outline the procedure for testing content uniformity in filled capsules to ensure each capsule contains the correct amount of active pharmaceutical ingredient (API) within specified limits.
2) Scope
This SOP applies to all capsule formulations manufactured within the facility that require content uniformity testing as per regulatory requirements.
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 and supporting QC during testing.
4) Procedure
4.1 Sample Selection:
4.1.1 Select representative samples of filled capsules from different batches.
4.1.2 Ensure samples are taken randomly and cover the entire batch production.
4.2 Sample Preparation:
4.2.1 Open capsules and disintegrate their contents to obtain a homogenous sample of API.
4.2.2 Prepare sample solutions or suspensions as per validated methods and dilutions if necessary.
4.2.3 Ensure samples are properly identified, labeled, and stored under appropriate conditions.
4.3 Content Uniformity Testing:
4.3.1 Analyze individual capsules or sample solutions using validated analytical methods, such as HPLC or UV-Vis spectroscopy.
4.3.2 Determine API content in each capsule or sample solution.
4.3.3 Calculate the mean and relative standard deviation (RSD) of API content across the sample set.
4.3.4 Compare results against acceptance criteria specified in pharmacopeial standards or internal specifications.
4.4 Calculation and Interpretation:
4.4.1 Calculate the mean content and RSD using validated formulas.
4.4.2 Evaluate content uniformity results to ensure compliance with specified limits.
4.4.3 Investigate and document any deviations from expected results, including outliers or non-uniformity.
4.5 Acceptance Criteria:
4.5.1 Capsules are considered uniform if the RSD of API content does not exceed predefined limits.
4.5.2 Ensure all analytical controls and method validation parameters meet predefined criteria.
4.6 Documentation:
4.6.1 Record all content uniformity testing procedures, results, and observations in the Content Uniformity Testing Record.
4.6.2 Maintain detailed records of sample preparation, testing conditions, and any deviations encountered.
4.6.3 Review and approve the documentation by QC Manager.
5) Abbreviations, if any
QC: Quality Control
API: Active Pharmaceutical Ingredient
HPLC: High Performance Liquid Chromatography
UV-Vis: Ultraviolet-Visible Spectroscopy
RSD: Relative Standard Deviation
6) Documents, if any
Content Uniformity Testing Record
Method Validation Report for Content Uniformity
Sampling Plan Document
7) Reference, if any
USP General Chapter <905> – Uniformity of Dosage Units
Pharmacopeial standards for Content Uniformity in Capsules
8) SOP Version
Version 1.0