Homogeneity Testing Procedures for MDIs

1) Purpose

The purpose of this SOP is to establish procedures for conducting homogeneity testing of metered-dose inhalers (MDIs) to ensure uniform distribution of active ingredients throughout the product batch.

2) Scope

This SOP applies to all personnel involved in homogeneity testing activities within the MDI production facility, including quality control technicians, analytical chemists, and production supervisors.

3) Responsibilities

The responsibilities for this SOP include performing homogeneity testing, interpreting test results, documenting findings, and ensuring compliance with specifications. Specific roles include:
Quality Control Technicians: Conduct homogeneity testing according to approved procedures.
Analytical Chemists: Analyze test results and assess uniformity of active ingredient distribution.
Production Supervisors: Review testing outcomes and authorize batch release based on test results.

4) Procedure

4.1 Sample Preparation
4.1.1 Prepare representative samples from different locations within the MDI batch.
4.1.2 Ensure samples are homogenized and properly labeled for identification.
4.2 Testing Method
4.2.1 Use validated analytical methods to analyze active ingredient content in samples.
4.2.2 Perform testing in triplicate or as per specified testing protocol.
4.3 Acceptance Criteria
4.3.1 Compare test results against established acceptance