Comprehensive Guide to Equipment Qualification Procedures (IQ, OQ, PQ) for Medical Device Manufacturing
1) Purpose
The purpose of this SOP is to define the process for qualifying equipment used in medical device manufacturing through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). This ensures that equipment operates as intended and consistently produces products meeting quality and regulatory standards.
2) Scope
This SOP applies to all equipment used in the production, assembly, and testing of medical devices. It includes the qualification procedures for new, modified, or repaired equipment and covers IQ, OQ, and PQ to ensure proper performance and compliance.
3) Responsibilities
– Engineering Team: Conducts IQ, OQ, and PQ testing and ensures that equipment is properly qualified.
– Quality Assurance (QA): Reviews qualification documentation and ensures that the qualification processes comply with regulatory and quality requirements.
– Facilities Management Team: Ensures that equipment is installed and maintained according to specifications.
– Manufacturing Team: Operates qualified equipment according to standard operating procedures and reports any issues.
– Regulatory Affairs: Ensures that equipment qualification complies with applicable regulatory requirements such as FDA and ISO standards.
– Document Control Team: Maintains records of all equipment qualifications and ensures proper version
4) Procedure
4.1 Equipment Qualification Overview
4.1.1 Understanding IQ, OQ, PQ
– Installation Qualification (IQ): Verifies that equipment is installed according to specifications, manufacturer instructions, and regulatory requirements.
– Operational Qualification (OQ): Confirms that equipment operates within its specified operating ranges under controlled conditions.
– Performance Qualification (PQ): Verifies that the equipment consistently performs under real-world operating conditions and produces acceptable results.
4.1.2 Equipment Identification and Tracking
– Assign unique identification to each piece of equipment to track its qualification status.
– Record equipment specifications, manufacturer details, and installation dates for future reference.
4.2 Installation Qualification (IQ)
4.2.1 IQ Preparation
– Ensure that the following pre-installation conditions are met before conducting IQ:
– Equipment specifications match the intended use.
– Installation location meets environmental requirements (e.g., temperature, humidity, space).
– Proper utility connections (e.g., power, water, compressed air) are available and meet requirements.
4.2.2 IQ Testing
– Verify equipment installation according to the manufacturer’s specifications and the approved design:
– Confirm correct assembly and component installation.
– Verify calibration of equipment and instruments.
– Check safety features (e.g., emergency shutoff, alarms) are functional.
– Inspect the equipment for any physical defects or damages.
4.2.3 Documenting IQ
– Record IQ results, including:
– Installation date and location.
– Equipment identification and serial numbers.
– Test results for installation checks.
– Corrective actions taken for any installation discrepancies.
4.2.4 Approval of IQ
– Review IQ results and approve the equipment for the next phase (OQ) if all requirements are met.
4.3 Operational Qualification (OQ)
4.3.1 OQ Preparation
– Define the operational parameters to be tested, including:
– Equipment settings (e.g., temperature, pressure, speed).
– Operational limits (e.g., maximum and minimum values).
– Environmental conditions under normal operating conditions.
4.3.2 OQ Testing
– Perform tests to verify that the equipment operates within the specified ranges:
– Run equipment through its full range of operation and verify performance against specified limits.
– Check control systems (e.g., software, alarms) for correct operation.
– Verify that the equipment produces consistent and reliable results.
4.3.3 Documenting OQ
– Record OQ results, including:
– Test conditions and results.
– Pass/fail outcomes for each operational test.
– Corrective actions taken if operational limits were not met.
4.3.4 Approval of OQ
– Review OQ results and approve the equipment for the next phase (PQ) if all operational conditions are met.
4.4 Performance Qualification (PQ)
4.4.1 PQ Preparation
– Define the performance criteria that the equipment must meet under actual operating conditions, including:
– Equipment output consistency.
– Product quality and compliance with specifications.
– System integration with other manufacturing equipment or processes.
4.4.2 PQ Testing
– Test the equipment under real manufacturing conditions:
– Run equipment with a typical load of materials or products.
– Confirm that equipment consistently meets quality specifications (e.g., product weight, dimensions, sterilization efficacy).
– Monitor equipment performance over multiple cycles or shifts to ensure reliability.
4.4.3 Documenting PQ
– Record PQ results, including:
– Performance test conditions and results.
– Equipment output and product quality data.
– Corrective actions taken if performance criteria were not met.
4.4.4 Approval of PQ
– Review PQ results to ensure that the equipment consistently meets operational requirements.
– Approve equipment for routine use if PQ is successful.
4.5 Ongoing Monitoring and Maintenance
4.5.1 Routine Equipment Monitoring
– Establish routine monitoring procedures to ensure that the equipment continues to operate within specified parameters. This may include:
– Periodic checks of operational parameters (e.g., pressure, temperature, cycle time).
– Ongoing calibration of measurement instruments and sensors.
– Daily, weekly, and monthly maintenance tasks.
4.5.2 Preventive Maintenance
– Develop a preventive maintenance schedule to prevent equipment failures:
– Regular inspections and cleaning of equipment.
– Lubrication of moving parts and replacement of worn components.
– Replacement of filters, seals, or gaskets as needed.
4.5.3 Corrective Actions and Requalification
– If any deviations are detected during routine monitoring, take corrective actions to restore the equipment to proper working order. In some cases, requalification (IQ, OQ, PQ) may be necessary.
4.6 Documentation and Record Keeping
4.6.1 Equipment Qualification Documentation
– Maintain comprehensive records for each piece of equipment, including:
– IQ, OQ, and PQ protocols and results.
– Calibration and maintenance logs.
– Corrective action records for any deviations.
– Qualification approval documents.
4.6.2 Retention Period
– Retain qualification records for a minimum of five years or as required by regulatory authorities.
5) Abbreviations
– IQ: Installation Qualification
– OQ: Operational Qualification
– PQ: Performance Qualification
– QA: Quality Assurance
– SOP: Standard Operating Procedure
– FDA: Food and Drug Administration
– ISO: International Organization for Standardization
6) Documents
– Equipment Qualification Protocols (IQ, OQ, PQ)
– Equipment Qualification Logs (IQ, OQ, PQ Results)
– Equipment Maintenance and Calibration Records
– Corrective Action Logs
7) Reference
– FDA CFR Title 21, Part 820: Quality System Regulation
– ISO 13485: Medical Devices – Quality Management Systems
– ISO 14971: Risk Management for Medical Devices
– EU MDR (Regulation (EU) 2017/745): General Safety and Performance Requirements
8) SOP Version
– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]
Annexure
Annexure 1: Equipment Qualification Log Template
| Date | Equipment ID | Qualification Type | Test Description | Results |
|---|---|---|---|---|
| DD/MM/YYYY | EQ-001 | IQ | Installation check for sterilizer | Pass |
Annexure 2: Corrective Action Log Template
| Date | Action ID | Issue Description | Corrective Action Taken | Responsible Person |
|---|---|---|---|---|
| DD/MM/YYYY | CA-001 | Temperature exceeded set limit | Recalibrated thermostat | Engineering Lead |