(installation, operation, performance).

What a Good DQ Typically Includes

• Design basis and scope: what’s covered and what’s not
• URS traceability: mapping URS clauses to design features (traceability matrix)
• Risk assessment: identifying critical design elements (CDEs) and required controls
• Materials of construction: product-contact surfaces, cleanability, extractables/leachables risk where relevant
• Utilities and environmental needs: HVAC class, differential pressure, temperature/RH limits, water quality
• Control system and alarms: setpoints, interlocks, data capture, audit trails (if computerized)
• Maintenance and calibration design: access, sensors, calibration points, spare parts approach
• Compliance references: EU GMP Annex 15 principles and lifecycle qualification expectations

Mini Example: URS-to-DQ Traceability (What Auditors Love)

Suppose your URS states: “The system shall prevent mix-ups and provide electronic audit trails for critical process parameters.” In DQ, you would document:

• Which design feature fulfills the requirement (e.g., barcode verification, recipe management, user roles)
• How audit trails are generated, secured, and reviewed
• Which alarms/interlocks prevent incorrect operation
• What test evidence will later verify it (OQ test cases, challenge tests)

Common Confusions (Avoid These Audit Traps)

• “DQ is the vendor brochure”: Not acceptable. DQ must be your documented assessment against URS and GMP.
• DQ after installation: Late DQ is a red flag; it suggests retrospective justification.
• Ignoring critical utilities: DQ must consider HVAC/water/air needs and how they affect quality.
• No risk rationale: If you can’t explain why a design element is critical, inspections get painful.

Audit-Ready Talking Points

• Show the URS, then show the DQ traceability matrix linking URS to design features
• Explain how risk assessment identified critical design elements and required controls
• Demonstrate that GMP aspects (cleanability, materials, contamination control) were built into design
• Explain how FAT/SAT results are used as supporting evidence (where applicable)

Practical Checklist: Quick DQ Review Before Approval

• Are all URS clauses addressed with clear references?
• Are critical design elements identified and justified by risk?
• Are GMP needs covered (cleaning, contamination control, materials, access)?
• Are alarms, interlocks, and data integrity expectations described?
• Is there a clear plan for how DQ requirements will be verified in OQ/PQ?

FAQs

What is the purpose of DQ in pharma?

DQ ensures the proposed design is fit for intended use, meets URS and GMP expectations, and includes the right controls before installation.

When should DQ be performed?

DQ is ideally completed before equipment fabrication is finalized and definitely before installation—so design issues can be corrected early.

Is DQ mandatory under GMP?

Regulators expect documented evidence that design decisions were appropriate and risk-based. DQ is the standard qualification deliverable used to demonstrate this.

Who prepares and approves DQ?

Typically the validation/engineering team prepares it with vendor input, and QA approves it (often with cross-functional review).

How does DQ link to FAT and SAT?

FAT/SAT can provide supporting evidence that key design features and functions are built correctly, but they do not replace DQ’s URS/GMP justification.