User Requirement Specification (URS) &
Design Qualification (DQ) in
Pharmaceutical Validation
Presented by: [Your Name]
[Organization] | [Date]
Overview
• Pharmaceutical validation ensures consistency, quality, and regulatory
compliance.
• URS and DQ are critical early-stage validation documents.
• Proper planning ensures right-first-time implementation and minimizes
risks.
User Requirement Specification
(URS)
• Formal document capturing user needs and expectations for
equipment/systems.
• Focuses on functionality, compliance, performance, and user safety.
• Acts as the foundation for vendor selection, design, and qualification.
Components of a Good URS
• ✔ Functional requirements (e.g., alarms, capacity, control systems)
• ✔ Regulatory expectations (GMP, FDA, EU standards)
• ✔ Materials of construction, calibration, and maintenance criteria
• ✔ Safety, ergonomics, and environmental considerations
Example: URS for HVAC System
• • Must maintain cleanroom classification ISO 7 (Grade C)
• • Temperature control: 20–25°C ±2°C
• • Humidity: 45–55% RH
• • Must integrate with Building Management System (BMS)
Design Qualification (DQ)
• DQ ensures that the design meets the requirements defined in the URS.
• Conducted by the user and/or vendor before installation (pre-IQ).
• Includes technical drawings, P&IDs, component specs, and compliance
checks.
Key Elements of DQ
• • Cross-verification against approved URS
• • Design documentation and engineering review
• • Material of construction checks
• • GxP and risk-based compliance review
URS vs DQ – Key Distinctions
• URS: 'What we need' → DQ: 'Does the design deliver it?'
• URS precedes design; DQ validates design alignment.
• Both documents are regulatory audit essentials and must be well-traced.
Validation Lifecycle
• 1. URS – Define needs and expectations
• 2. DQ – Confirm design meets needs
• 3. IQ – Verify installation
• 4. OQ – Verify functionality
• 5. PQ – Verify consistent performance
Compliance Expectations
• • FDA 21 CFR Part 11 & cGMP guidelines
• • EU GMP Annex 15 (Qualification and Validation)
• • WHO Technical Reports on validation principles
Best Practices
• ✅ Involve multidisciplinary teams during URS drafting
• ✅ Maintain traceability matrix (URS ↔ DQ)
• ✅ Align with risk management principles (ICH Q9)
• ✅ Ensure documentation follows GDP (Good Documentation Practice)
Common Pitfalls
• ⚠ Vague or overly generic URS
• ⚠ Skipping user reviews or SME involvement
• ⚠ Performing DQ post-installation (non-compliant)
• ⚠ Lack of cross-reference between URS and DQ
Conclusion
• URS defines what’s required; DQ confirms design fulfills it.
• Both are integral to a compliant, well-controlled validation lifecycle.
• Robust documentation ensures audit readiness and process efficiency.
References
• • ICH Q8, Q9, Q10 Guidelines
• • EU GMP Annex 15
• • FDA Process Validation Guidance (2011)
• • WHO Technical Report Series (TRS)
Questions & Answers
• Thank you for your attention.
• Let’s discuss your questions or specific case scenarios.
