Comprehensive Guide to Manufacturing Process Validation (IQ, OQ, PQ) in Medical Device Manufacturing
1) Purpose
The purpose of this SOP is to outline the procedures for performing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in manufacturing process validation. This ensures that processes consistently produce products meeting predetermined specifications and quality attributes.
2) Scope
This SOP applies to all manufacturing processes requiring validation as part of medical device production. It includes new equipment or process implementation, significant process changes, and periodic revalidation. It is applicable to production engineers, quality assurance, and validation teams.
3) Responsibilities
– Validation Team: Plans and executes IQ, OQ, and PQ activities and compiles validation reports.
– Quality Assurance (QA): Reviews validation protocols, monitors activities, and approves validation results.
– Production Team: Assists with executing validation protocols and provides process input.
– Maintenance Team: Ensures equipment is properly installed and calibrated before validation.
4) Procedure
4.1 Planning and Preparation
4.1.1 Validation Master Plan
– Develop a Validation Master Plan (VMP) detailing objectives, scope, and responsibilities for IQ, OQ, and PQ.
– Identify critical processes and equipment requiring validation.
4.1.2 Protocol Development
– Create specific protocols for IQ, OQ, and PQ with predefined acceptance criteria.
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4.1.3 Documentation Review
– Verify that user requirements, equipment specifications, and calibration records are available and up to date.
4.2 Installation Qualification (IQ)
4.2.1 Objective
– Ensure equipment is installed correctly per manufacturer’s recommendations and design specifications.
4.2.2 Activities
– Verify that equipment components, utilities, and connections are installed as specified.
– Confirm that all instruments are calibrated and have current certificates.
– Document all activities using an IQ checklist.
4.2.3 Documentation
– Record installation details, including serial numbers, model numbers, and installation date.
– Capture photographs of equipment and utility connections for reference.
4.3 Operational Qualification (OQ)
4.3.1 Objective
– Verify that the equipment operates as intended under defined conditions.
4.3.2 Activities
– Conduct functional testing to confirm performance meets operational specifications.
– Simulate worst-case operating conditions and document results.
– Test critical control points, including temperature, pressure, and speed, where applicable.
4.3.3 Documentation
– Record test data, including setpoints, actual readings, and deviations.
– Annotate adjustments made during OQ to optimize performance.
4.4 Performance Qualification (PQ)
4.4.1 Objective
– Demonstrate that the process consistently produces outputs meeting quality requirements under normal production conditions.
4.4.2 Activities
– Run production batches using actual materials and settings.
– Monitor key performance indicators (KPIs), such as yield, cycle time, and defect rates.
– Evaluate product quality through inspections and testing at predefined intervals.
4.4.3 Documentation
– Maintain batch records, inspection results, and test reports.
– Include statistical analysis to validate process capability and consistency.
4.5 Deviations and Corrective Actions
4.5.1 Identifying Deviations
– Document any deviations observed during IQ, OQ, or PQ activities.
– Categorize deviations based on their impact on validation outcomes.
4.5.2 Implementing Corrective Actions
– Investigate root causes of deviations and implement corrective actions.
– Update protocols or equipment settings to address identified issues.
4.6 Validation Reporting and Approval
4.6.1 Compile Validation Reports
– Consolidate results from IQ, OQ, and PQ activities into a comprehensive validation report.
– Highlight acceptance criteria, test results, deviations, and corrective actions.
4.6.2 Review and Approval
– Submit validation reports for QA review and approval.
– Obtain final approval from the validation team leader or department head before using the equipment or process in production.
5) Abbreviations
– IQ: Installation Qualification
– OQ: Operational Qualification
– PQ: Performance Qualification
– QA: Quality Assurance
– VMP: Validation Master Plan
6) Documents
– Validation Master Plan
– IQ Protocol and Checklist
– OQ Protocol and Test Records
– PQ Protocol and Batch Records
– Validation Report
7) Reference
– ISO 13485: Medical devices – Quality management systems
– FDA CFR Title 21, Part 820: Quality System Regulation
– GHTF Guidelines: Process Validation for Medical Device Manufacturing
8) SOP Version
– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]
Annexure
Annexure 1: IQ Checklist Template
| Equipment Name | Serial Number | Installation Date | Installer | Remarks |
|---|---|---|---|---|
| Equipment Name | Serial Number | DD/MM/YYYY | Installer Name | Comments |
Annexure 2: OQ Test Record Template
| Test Parameter | Setpoint | Actual Reading | Pass/Fail | Remarks |
|---|---|---|---|---|
| Parameter | Setpoint Value | Actual Value | Pass/Fail | Comments |
Annexure 3: PQ Batch Record Template
| Batch Number | Production Date | Key Performance Indicators | Results | Remarks |
|---|---|---|---|---|
| Batch ID | DD/MM/YYYY | KPI Details | Measured Values | Comments |