Assay Procedures for Active Ingredient in MDIs

1) Purpose

The purpose of this SOP is to establish procedures for the assay of the active ingredient in metered-dose inhalers (MDIs) to determine its concentration and ensure product quality and consistency.

2) Scope

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

3) Responsibilities

The responsibilities for this SOP include conducting assay testing, interpreting assay results, documenting findings, and ensuring compliance with specifications. Specific roles include:
Analytical Chemists: Perform assay testing using validated methods and equipment.
Quality Control Technicians: Verify assay results and ensure accuracy and precision of testing.
Production Supervisors: Review assay data and authorize batch release based on assay results.

4) Procedure

4.1 Sample Preparation
4.1.1 Prepare representative samples of MDIs for assay testing.
4.1.2 Ensure samples are accurately weighed or measured according to testing requirements.
4.2 Assay Method
4.2.1 Use validated analytical methods (e.g., chromatography, spectroscopy) to determine active ingredient concentration.
4.2.2 Perform assay testing in triplicate or as per specified testing protocol.
4.3 Calculation