Design qualification (DQ) MCQs With Answer

Design qualification (DQ) MCQs With Answer

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Design Qualification (DQ) MCQs With Answer

Introduction: Design Qualification (DQ) is a critical phase in pharmaceutical facility and equipment lifecycle, ensuring that design outputs meet predefined user requirements and regulatory expectations. For M.Pharm students specializing in Pharmaceutical Validation, mastering DQ concepts is essential for developing compliant manufacturing systems, controlling contamination risks, and guaranteeing product quality. This quiz set explores in-depth DQ topics including User Requirement Specifications (URS), Functional Design Specifications (FDS), risk assessments, HVAC and cleanroom design principles, utilities, materials of construction, process flows, and documentation. These questions emphasize practical understanding, regulatory linkage, and decision-making skills needed for preparing and reviewing DQ documentation in real-world pharmaceutical projects.

Q1. Which document captures the detailed needs and expectations of the end user that serve as the primary input for Design Qualification?

  • User Requirement Specification (URS)
  • Equipment Logbook
  • Installation Qualification Protocol (IQ)
  • Validation Master Plan (VMP)

Correct Answer: User Requirement Specification (URS)

Q2. In the DQ process, the Functional Design Specification (FDS) primarily translates the URS into which of the following?

  • Operational performance criteria and technical details
  • Daily maintenance checklists
  • Raw material specifications
  • Marketing authorization dossier

Correct Answer: Operational performance criteria and technical details

Q3. Which risk assessment methodology is commonly used during DQ to prioritize design items for control and verification?

  • Failure Mode and Effects Analysis (FMEA)
  • Root Cause Analysis (RCA)
  • Six Sigma DMAIC only
  • Pareto Analysis exclusively

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q4. Which aspect of HVAC design is most critical to demonstrate in DQ for sterile manufacturing suites?

  • Airflow pattern, pressure differentials, and filtration efficiency
  • Color of duct painting
  • Type of lighting fixtures used
  • Vendor brand of fans

Correct Answer: Airflow pattern, pressure differentials, and filtration efficiency

Q5. During DQ, which of the following is the best evidence that an equipment design prevents cross-contamination?

  • Clear segregation of product contact and non-product contact zones with validated cleanability
  • Vendor claim in a brochure
  • Generic industry guidance references without tailoring
  • Purchase order mentioning “contamination control”

Correct Answer: Clear segregation of product contact and non-product contact zones with validated cleanability

Q6. Which of the following is a primary DQ acceptance criterion for a process control system?

  • Specification of alarm limits, interlocks, and data integrity protections
  • Color of the Human-Machine Interface (HMI)
  • Number of vendors who quote the system
  • Inclusion of a promotional video

Correct Answer: Specification of alarm limits, interlocks, and data integrity protections

Q7. What is the role of code of practice and regulatory standards (e.g., GMP, ISO) in DQ documentation?

  • They provide design constraints and compliance requirements to be referenced in design outputs
  • They replace the need for URS and FDS
  • They are optional recommendations with no impact on DQ
  • They only apply during commercial distribution

Correct Answer: They provide design constraints and compliance requirements to be referenced in design outputs

Q8. Which statement best describes traceability requirements in DQ documentation?

  • Each design requirement must be traceable to design outputs, tests, and acceptance criteria
  • Only the final test reports need to be traceable
  • Traceability is only required for electronic systems
  • Traceability may be omitted for non-critical equipment

Correct Answer: Each design requirement must be traceable to design outputs, tests, and acceptance criteria

Q9. For piping systems included in DQ, which design feature is essential to ensure maintainability and cleaning?

  • Appropriate slope for drainability, accessible joints, and sanitary fittings
  • Use of decorative paint on pipes
  • Maximizing number of elbows to fit space
  • Omitting isolation valves to reduce cost

Correct Answer: Appropriate slope for drainability, accessible joints, and sanitary fittings

Q10. Which component of DQ should define calibration strategy and critical measurement tolerances?

  • Instrumentation and Control Design Specifications within the FDS
  • Promotional materials from instrument vendor
  • Building lease agreement
  • Packing list of delivered spares

Correct Answer: Instrumentation and Control Design Specifications within the FDS

Q11. How should material of construction selections be handled during DQ for product-contact parts?

  • Specify materials compatible with product chemistry, cleanability, and regulatory expectations
  • Choose the cheapest available material
  • Rely solely on supplier standard materials without assessment
  • Prefer materials that require special disposal to avoid cleaning

Correct Answer: Specify materials compatible with product chemistry, cleanability, and regulatory expectations

Q12. Which document prepared during DQ defines commissioning, qualification and validation deliverables and responsibilities?

  • Validation Master Plan (VMP)
  • Maintenance Logbook
  • Purchase Requisition
  • Vendor Confidentiality Agreement

Correct Answer: Validation Master Plan (VMP)

Q13. During design reviews in DQ, which stakeholder input is most critical to ensure operability and maintainability?

  • Input from operations, engineering, quality assurance, and maintenance teams
  • Only vendor sales representatives
  • Marketing and procurement exclusively
  • External auditors only after installation

Correct Answer: Input from operations, engineering, quality assurance, and maintenance teams

Q14. Which performance characteristic should be specified in DQ for sterilization equipment used in aseptic processing?

  • Cycle parameters, biological indicator acceptance, and load mapping criteria
  • Manufacturer phone number
  • Color of the sterilizer door
  • Preferred shipping route to the site

Correct Answer: Cycle parameters, biological indicator acceptance, and load mapping criteria

Q15. How should software and computerized systems be addressed in DQ for regulated facilities?

  • Define functional requirements, security, audit trails, and data integrity controls
  • Allow unlimited user access without controls
  • Exclude software from DQ because it is not physical equipment
  • Document only hardware specifications

Correct Answer: Define functional requirements, security, audit trails, and data integrity controls

Q16. Which validation-related test is typically derived from DQ and executed during IQ/OQ?

  • Specific acceptance tests for performance, safety interlocks, and design criteria
  • Marketing acceptance of product labels
  • Employee satisfaction surveys
  • Generic smoke tests unrelated to process parameters

Correct Answer: Specific acceptance tests for performance, safety interlocks, and design criteria

Q17. What is the importance of defining critical process parameters (CPPs) in the DQ stage?

  • CPPs guide control strategy, testing requirements, and acceptance criteria for qualification
  • CPPs are only useful after product launch for marketing
  • CPPs should be decided during routine production without design input
  • CPPs are the same for all processes and need no specification

Correct Answer: CPPs guide control strategy, testing requirements, and acceptance criteria for qualification

Q18. When performing DQ for a multi-product facility, which design approach is most appropriate to control cross-contamination?

  • Use of dedicated containment, validated changeover procedures, and segregated product flows
  • Shared open systems with only time-based cleaning
  • Rely exclusively on visual inspection between products
  • Scheduling without technical segregation or validation

Correct Answer: Use of dedicated containment, validated changeover procedures, and segregated product flows

Q19. Which element is essential in the DQ to ensure future maintainability and spare parts planning?

  • Bill of Materials (BOM), critical spare parts list, and recommended maintenance intervals
  • Only the initial invoice for equipment
  • Vague note saying “spares as needed”
  • Detailed color photographs without part identifiers

Correct Answer: Bill of Materials (BOM), critical spare parts list, and recommended maintenance intervals

Q20. How should deviations discovered during commissioning that affect DQ acceptance criteria be handled?

  • Evaluate risk, document deviation, implement corrective actions, and revise DQ if necessary
  • Ignore them if minor and proceed to qualification
  • Destroy all related documentation to avoid records
  • Delay any decision until after product release

Correct Answer: Evaluate risk, document deviation, implement corrective actions, and revise DQ if necessary

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