Quality Assurance Procedures for MDIs
1) Purpose
The purpose of this SOP is to establish the procedures for quality control testing of metered-dose inhalers (MDIs) to ensure they meet the required specifications and regulatory standards.
2) Scope
This SOP applies to all quality control personnel involved in testing MDIs at the manufacturing facility, including chemists and laboratory technicians.
3) Responsibilities
The responsibilities for this SOP include conducting tests accurately, documenting results, and ensuring compliance with established standards. Specific roles include:
Chemists: Perform the quality control tests as specified.
Laboratory Technicians: Assist in sample preparation and testing.
Quality Control Supervisors: Review and approve test results and documentation.
4) Procedure
4.1 Sample Collection
4.1.1 Collect samples from each batch of MDIs following the sampling plan.
4.1.2 Label and record the samples appropriately.
4.2 Physical Tests
4.2.1 Inspect the MDIs for visual defects.
4.2.2 Measure the weight and dimensions of the MDIs.
4.3 Chemical Tests
4.3.1 Perform assays to determine the active ingredient content.
4.3.2 Conduct impurity profiling to ensure product purity.
4.4 Performance Tests
4.4.1 Test the aerosol performance, including dose uniformity and spray pattern.
4.4.2 Measure the particle size distribution using appropriate techniques.
4.5 Microbial Tests
4.5.1 Conduct microbial limit tests to ensure the product is free from harmful microorganisms.
4.5.2 Perform sterility tests as required.
4.6 Documentation
4.6.1 Record all test results in the quality control logbook.
4.6.2 Review and approve the test results and ensure they meet the acceptance criteria.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
6) Documents, if any
Quality control test reports, sample collection records, and laboratory notebooks should be maintained.
7) Reference, if any
Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for quality control testing standards.
8) SOP Version
Version 1.0
