MDI Stability Testing Procedures

1) Purpose

The purpose of this SOP is to outline the procedures for conducting stability testing of metered-dose inhalers (MDIs) to ensure they maintain their quality, safety, and efficacy throughout their shelf life.

2) Scope

This SOP applies to all personnel involved in the stability testing of MDIs at the manufacturing facility, including laboratory technicians and quality control staff.

3) Responsibilities

The responsibilities for this SOP include conducting stability tests according to the outlined procedures, documenting results, and ensuring compliance with regulatory standards. Specific roles include:
Laboratory Technicians: Perform stability testing as specified.
Quality Control Staff: Review and document the results of stability tests.

4) Procedure

4.1 Sample Preparation
4.1.1 Collect MDI samples from each batch according to the sampling plan.
4.1.2 Label and store samples under specified conditions (e.g., temperature, humidity).
4.2 Stability Testing Conditions
4.2.1 Conduct stability tests at different conditions such as long-term, accelerated, and stress conditions as per the stability protocol.
4.2.2 Record environmental conditions during testing.
4.3 Test Parameters
4.3.1 Perform physical tests (e.g., appearance, color, container integrity).
4.3.2 Conduct chemical tests (e.g., assay, impurities).
4.3.3 Perform performance tests (e.g., dose uniformity, spray pattern).
4.3.4 Conduct microbial tests if applicable.
4.4 Data Recording
4.4.1 Document all test results in the stability testing logbook.
4.4.2 Ensure data integrity and compliance with Good Laboratory Practice (GLP) guidelines.
4.5 Review and Analysis
4.5.1 Analyze the stability data to determine trends and product shelf life.
4.5.2 Review results and prepare a stability report.
4.6 Reporting
4.6.1 Submit stability reports to the quality assurance department for approval.
4.6.2 Update the stability testing schedule as required.

5) Abbreviations, if any

MDI: Metered-Dose Inhaler

6) Documents, if any

Stability testing protocols, stability reports, and environmental monitoring records should be maintained.

7) Reference, if any

Refer to regulatory guidelines from agencies such as the FDA, EMA, and ICH for stability testing standards.

8) SOP Version

Version 1.0