‘A life-cycle is defined as per Clause 3.9
Pharmaceutical Lifecycle Validation
Complete Validation Lifecycle with Document Templates
Click on any phase to see details
Select a phase to view document templates
Phase 1
📋 PLANNING & STRATEGY
Validation Master Plan (VMP)
Risk Assessment
Team Formation
Phase 2
📝 URS
User Requirements Specification
Define System Needs
Regulatory Requirements
Phase 3
🎯 DQ
Design Qualification
Verify Design Meets URS
Design Review & Approval
⚙️ QUALIFICATION TRIAD
Phase 4
🔧 IQ
Installation Qualification
Equipment Installation
Verify Components
Documentation Review
Phase 5
⚡ OQ
Operational Qualification
Functional Testing
Operating Range Verification
Calibration
Phase 6
✅ PQ
Performance Qualification
Process Validation
Consistency Verification
Product Quality Confirmation
Phase 7
📊 CPV
Continuous Process Verification
Ongoing Monitoring
Statistical Analysis
Phase 8
🔄 PERIODIC REVIEW
Annual Product Review
Validation Status Check
Deviation Analysis
Phase 9
🔀 CHANGE CONTROL
Impact Assessment
Revalidation Needs
Documentation Updates
Phase 10
🔁 REVALIDATION
Scheduled Revalidation
Post-Change Validation
Lifecycle Maintenance
Phase 11
🏁 RETIREMENT
Decommissioning Plan
Data Archival
Final Documentation
Key Regulatory References
📖
FDA 21 CFR Part 211
cGMP Regulations
📘
ICH Q7
API Manufacturing GMP
📗
GAMP 5
Computerized Systems Validation
📕
EU GMP Annex 15
Qualification and Validation
📋
Validation Master Plan
Comprehensive validation strategy document
Phase 1: Planning & Strategy
📝
User Requirements Specification
Define system and process requirements
Phase 2: URS
🎯
Design Qualification Protocol
Verify design meets requirements
Phase 3: DQ
🔧
Installation Qualification Protocol
Verify correct installation
Phase 4: IQ
⚡
Operational Qualification Protocol
Test operational performance
Phase 5: OQ
✅
Performance Qualification Protocol
Validate process consistency
Phase 6: PQ
📊
CPV Plan
Continuous monitoring strategy
Phase 7: CPV
🔀
Change Control Form
Document and assess changes
Phase 9: Change Control
⚠️
Deviation Report
Document non-conformances
All Phases
🎲
Risk Assessment Matrix
Evaluate and prioritize risks
All Phases
🔗
Traceability Matrix
Link requirements to tests
All Qualification Phases
🏁
Decommissioning Plan
Retirement documentation
Phase 11: Retirement