Equipment Qualification Procedures in MDI Production

1) Purpose

The purpose of this SOP is to establish procedures for equipment qualification in metered-dose inhaler (MDI) production to ensure equipment performance, reliability, and compliance with regulatory requirements.

2) Scope

This SOP applies to all equipment used in MDI production, including but not limited to filling machines, mixing vessels, blending equipment, and packaging machinery.

3) Responsibilities

The responsibilities for this SOP include conducting qualification studies, documenting results, and ensuring equipment meets operational and regulatory standards.

4) Procedure
4.1 Equipment Identification

4.1.1 Maintain an inventory of all equipment used in MDI production, including serial numbers and calibration schedules.

4.1.2 Assign unique identification numbers or labels to each piece of equipment for tracking purposes.

4.2 Installation Qualification (IQ)

4.2.1 Verify that equipment is correctly installed according to manufacturer specifications and facility requirements.

4.2.2 Document installation details, including location, utilities connections, and installation checks.

4.3 Operational Qualification (OQ)

4.3.1 Perform operational tests to ensure equipment operates as intended under normal production conditions.

4.3.2 Test equipment functions, controls, alarms, and safety features during OQ studies.

4.4 Performance Qualification (PQ)

4.4.1 Conduct performance tests using representative product or process materials to demonstrate equipment consistently produces acceptable results.

4.4.2 Define acceptance criteria for PQ studies based on process requirements and regulatory