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 criteria for homogeneity.
4.3.2 Determine compliance with specifications based on test results.
4.4 Documentation
4.4.1 Record homogeneity testing procedures, including sample preparation methods and analytical techniques used.
4.4.2 Document test results, deviations observed, and any corrective actions taken.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
6) Documents, if any
Homogeneity testing protocols, test 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 homogeneity testing requirements in pharmaceutical manufacturing.
8) SOP Version
Version 1.0