Standard Operating Procedure for Equipment Qualification in Aerosol Production
1) Purpose
The purpose of this SOP is to define procedures for the qualification of equipment used in aerosol production. Equipment qualification ensures that all production equipment operates according to specified requirements, consistently producing aerosol products of high quality and meeting regulatory standards.
2) Scope
This SOP applies to all equipment used in aerosol production at [Company Name], including but not limited to filling machines, propellant filling units, mixing vessels, and analytical instruments.
3) Responsibilities
Quality Assurance (QA) Manager: Oversee equipment qualification activities and ensure compliance with procedures.
Production Manager: Coordinate equipment qualification schedules with production schedules.
Validation Team: Perform qualification tests and maintain qualification records.
All Personnel: Report any equipment malfunctions or deviations from qualification criteria.
4) Procedure
4.1 Equipment Qualification Planning:
4.1.1 Identify equipment requiring qualification based on risk assessment and regulatory requirements.
4.1.2 Develop a qualification plan outlining the scope, objectives, and acceptance criteria for each equipment qualification.
4.1.3 Obtain approval for the qualification plan from relevant stakeholders before proceeding.
4.2 Installation Qualification (IQ):
4.2.1 Verify that equipment is installed correctly and according to manufacturer specifications.
4.2.2 Document equipment installation details, including location, utilities, and environmental conditions.
4.2.3 Perform inspections and checks to ensure all components are installed and connected as per design.
4.3 Operational Qualification (OQ):
4.3.1 Validate that equipment operates as intended throughout its operational range.
4.3.2 Conduct performance tests and functional checks to verify equipment functions meet specified requirements.
4.3.3 Record OQ test results and compare against acceptance criteria defined in the qualification plan.
4.4 Performance Qualification (PQ):
4.4.1 Demonstrate that equipment consistently produces aerosol products meeting quality specifications.
4.4.2 Conduct production simulations or use worst-case scenarios to challenge equipment performance.
4.4.3 Analyze PQ data and verify compliance with predetermined acceptance criteria.
4.5 Requalification and Maintenance:
4.5.1 Establish a requalification schedule based on equipment criticality and regulatory requirements.
4.5.2 Perform periodic requalification activities as per schedule and documented procedures.
4.5.3 Maintain equipment in a qualified state through routine maintenance and calibration activities.
4.6 Documentation and Record Keeping:
4.6.1 Generate comprehensive qualification reports for each equipment qualification phase (IQ, OQ, PQ).
4.6.2 Maintain accurate and up-to-date records of all qualification activities, including test protocols, results, and deviations.
4.6.3 Archive qualification records in a secure location for future reference and regulatory inspections.
5) Abbreviations, if any
IQ: Installation Qualification
OQ: Operational Qualification
PQ: Performance Qualification
QA: Quality Assurance
SOP: Standard Operating Procedure
6) Documents, if any
Equipment Qualification Plan
IQ, OQ, PQ Test Protocols
Qualification Reports
Requalification Schedule
7) Reference, if any
GMP Guidelines
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
FDA Guidance for Industry: Process Validation: General Principles and Practices
8) SOP Version
Version 1.0
