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 and Reporting
4.3.1 Calculate the concentration of the active ingredient based on assay results and calibration standards.
4.3.2 Prepare assay reports documenting test procedures, results, and calculations performed.
4.4 Documentation
4.4.1 Record assay testing procedures, including sample preparation methods and analytical techniques used.
4.4.2 Document assay results, deviations observed, and any corrective actions taken.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
6) Documents, if any
Assay testing protocols, assay records, analytical method validations, and batch release certificates should be maintained.
7) Reference, if any
Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for assay testing requirements in pharmaceutical manufacturing.
8) SOP Version
Version 1.0
