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 guidelines.
4.5 Requalification and Maintenance
4.5.1 Establish a requalification schedule based on equipment criticality and operational use.
4.5.2 Perform periodic requalification activities and document maintenance activities to ensure equipment continues to perform within specifications.
4.6 Documentation and Reporting
4.6.1 Maintain comprehensive records of equipment qualification activities, including protocols, test results, deviations, and corrective actions.
4.6.2 Prepare qualification reports summarizing findings, conclusions, and recommendations for equipment use and maintenance.
5) Abbreviations, if any
MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
IQ: Installation Qualification
OQ: Operational Qualification
PQ: Performance Qualification
6) Documents, if any
Equipment qualification protocols, qualification reports, maintenance logs, and calibration certificates should be maintained as part of the quality management system.
7) Reference, if any
Refer to equipment qualification guidelines from regulatory agencies, industry standards, and equipment manufacturers.
8) SOP Version
Version 1.0
