Premises and equipment qualification and validation during technology transfer are essential for ensuring consistent, GMP-compliant pharmaceutical manufacturing. For B. Pharm students, this topic covers Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), calibration, commissioning, cleaning validation, and FAT/SAT activities. You will learn about risk assessment, acceptance criteria, environmental monitoring, utilities (HVAC, WFI), computer system validation (CSV), change control, traceability matrices, and documentation practices. Mastery of these concepts safeguards product quality, critical process parameters (CPPs), critical quality attributes (CQAs), and data integrity during scale-up or site transfers. Topics also include cleanroom classification, qualification lifecycle, and traceability matrices to ensure reproducible manufacturing. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary objective of Installation Qualification (IQ)?
- To establish routine maintenance schedules for equipment
- To document and verify that equipment and utilities are installed according to design and manufacturer’s specifications
- To validate the cleaning procedure for the equipment
- To demonstrate process robustness under production conditions
Correct Answer: To document and verify that equipment and utilities are installed according to design and manufacturer’s specifications
Q2. Which stage of qualification verifies that the equipment consistently performs within predetermined limits under simulated or actual production conditions?
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
Correct Answer: Performance Qualification (PQ)
Q3. During technology transfer, what is the main purpose of a Factory Acceptance Test (FAT)?
- To test cleaning procedures after installation
- To verify equipment functionality and specifications at the vendor’s site before shipment
- To perform stability studies on the product
- To conduct environmental monitoring in the target facility
Correct Answer: To verify equipment functionality and specifications at the vendor’s site before shipment
Q4. Which document formally captures user requirements that guide Design Qualification (DQ)?
- IQ Protocol
- URD / User Requirements Specification (URS)
- SOP for Operation
- Calibration Certificate
Correct Answer: URD / User Requirements Specification (URS)
Q5. What is a critical acceptance criterion for Operational Qualification (OQ)?
- That the equipment was manufactured by an approved vendor
- That the installation location is aesthetically pleasing
- That equipment functions reproducibly within specified operational ranges
- That all operators have completed university coursework
Correct Answer: That equipment functions reproducibly within specified operational ranges
Q6. Which qualification activity focuses on confirming the design meets user requirements and regulatory expectations before purchase or installation?
- Performance Qualification (PQ)
- Design Qualification (DQ)
- Operational Qualification (OQ)
- Cleaning Validation
Correct Answer: Design Qualification (DQ)
Q7. What is the role of calibration in equipment qualification?
- To clean equipment parts after manufacturing
- To adjust equipment to meet manufacturing throughput targets
- To ensure measuring instruments provide accurate and traceable readings against standards
- To certify personnel competency
Correct Answer: To ensure measuring instruments provide accurate and traceable readings against standards
Q8. Which risk assessment tool is commonly used during technology transfer to prioritize equipment and process risks?
- Root Cause Analysis (RCA)
- Failure Mode and Effects Analysis (FMEA)
- Product Stability Index (PSI)
- Batch Yield Calculation
Correct Answer: Failure Mode and Effects Analysis (FMEA)
Q9. What is the main objective of Performance Qualification (PQ)?
- To install equipment according to drawings
- To prove that the process performs effectively and reproducibly under routine production conditions
- To validate the supplier audit process
- To train maintenance staff
Correct Answer: To prove that the process performs effectively and reproducibly under routine production conditions
Q10. During technology transfer, the Site Acceptance Test (SAT) is performed to:
- Assess the financial viability of the transfer
- Verify equipment and system performance after installation at the receiving site
- Finalize product labelling and packaging
- Train marketing personnel
Correct Answer: Verify equipment and system performance after installation at the receiving site
Q11. Which of the following is a critical utility to qualify when transferring sterile manufacturing processes?
- Compressed air and HVAC systems
- Office lighting
- Parking lot drainage
- Marketing email server
Correct Answer: Compressed air and HVAC systems
Q12. What does CSV stand for and why is it important during technology transfer?
- Computer System Validation; ensures software and computerized systems are fit for intended use and data integrity
- Calibration Schedule Verification; schedules calibration events
- Cleaning Schedule Validation; ensures cleaning timelines are met
- Certificate of System Value; appraises equipment cost
Correct Answer: Computer System Validation; ensures software and computerized systems are fit for intended use and data integrity
Q13. Which document records deviations, observations, and acceptance status during a qualification protocol?
- Deviation Log / Protocol Report
- Marketing Plan
- Purchase Order
- Employee Timesheet
Correct Answer: Deviation Log / Protocol Report
Q14. What is an example of a Critical Quality Attribute (CQA) that may be affected by equipment qualification?
- Supplier corporate logo
- Assay potency of the drug product
- Employee job title
- Invoice number
Correct Answer: Assay potency of the drug product
Q15. Which sampling method is commonly used in cleaning validation to assess residuals on equipment surfaces?
- Environmental air settle plates
- Swab and rinse sampling
- Bulk powder tapping
- Packaging tensile testing
Correct Answer: Swab and rinse sampling
Q16. What is the first step in a formal technology transfer for a manufacturing process?
- Conducting PQ
- Performing OQ
- Preparing a Transfer Plan and defining scope, deliverables, and responsibilities
- Label design approval
Correct Answer: Preparing a Transfer Plan and defining scope, deliverables, and responsibilities
Q17. In qualification terminology, which activity typically follows IQ?
- Design Qualification (DQ)
- Performance Qualification (PQ)
- Operational Qualification (OQ)
- Final product release
Correct Answer: Operational Qualification (OQ)
Q18. Why are traceability matrices important during technology transfer qualification?
- They provide financial tracking of equipment costs
- They map requirements to tests and documentation to ensure coverage and traceability
- They schedule staff rotations
- They determine packaging aesthetics
Correct Answer: They map requirements to tests and documentation to ensure coverage and traceability
Q19. Which environmental parameter is most critical to monitor in a cleanroom during qualification?
- Ambient music volume
- Particle counts and differential pressure
- Cafeteria menu options
- Telephone signal strength
Correct Answer: Particle counts and differential pressure
Q20. What is the purpose of periodic requalification of equipment?
- To update company branding
- To verify continued suitability and performance over time and after major changes
- To hire new personnel
- To reduce inventory levels
Correct Answer: To verify continued suitability and performance over time and after major changes
Q21. During OQ, which test would ensure a thermal cycle in a sterilizer meets setpoints and uniformity?
- Media fill challenge
- Temperature mapping and distribution tests
- Swab sampling of surfaces
- Visual inspection of chamber paint
Correct Answer: Temperature mapping and distribution tests
Q22. Which regulatory concept requires documented evidence that premises and equipment are suitable and maintained?
- Good Manufacturing Practice (GMP)
- Good Advertising Practice (GAdP)
- Good Logistics Practice (GLP)
- Good Culinary Practice (GCP)
Correct Answer: Good Manufacturing Practice (GMP)
Q23. What is a common acceptance criterion used in qualification protocols?
- Subjective operator satisfaction
- Numerical limits based on design and regulatory requirements
- Lowest purchase price
- Vendor location proximity
Correct Answer: Numerical limits based on design and regulatory requirements
Q24. Which of the following best describes a commissioning activity?
- Operational transfer of validated batches to the market
- Initial start-up, testing and verification of systems before formal qualification
- Marketing authorization application submission
- Employee onboarding
Correct Answer: Initial start-up, testing and verification of systems before formal qualification
Q25. In cleaning validation, worst-case selection refers to:
- Choosing the earliest manufactured batch for testing
- Selecting the product, equipment location, and conditions most difficult to clean
- Using the least sensitive analytical method available
- Testing only the most frequently cleaned equipment
Correct Answer: Selecting the product, equipment location, and conditions most difficult to clean
Q26. What is the significance of acceptance criteria in a qualification protocol?
- They are optional suggestions for future studies
- They define the measurable limits that determine success or failure of tests
- They determine staff salaries
- They list vendor preferred colors for equipment
Correct Answer: They define the measurable limits that determine success or failure of tests
Q27. Which test is commonly used to demonstrate aseptic process performance during technology transfer?
- Cleaning visual inspection
- Media fill (aseptic simulation)
- Thermal mapping of HVAC
- Packaging drop test
Correct Answer: Media fill (aseptic simulation)
Q28. Why is documentation control critical in premises and equipment qualification?
- To prevent overuse of stationery
- To provide auditable evidence, ensure version control, and enable reproducibility
- To limit access to the lunchroom
- To increase paperwork for staff
Correct Answer: To provide auditable evidence, ensure version control, and enable reproducibility
Q29. When is a requalification typically required?
- Only when production volume increases
- After significant maintenance, relocation, modification, or periodic schedule
- Only when a complaint is received
- Every day before production starts
Correct Answer: After significant maintenance, relocation, modification, or periodic schedule
Q30. In technology transfer, the transfer report should primarily include:
- List of marketing channels
- Detailed comparison of processes, qualification results, deviations, open items, and recommendations
- Only the purchase orders of equipment
- A summary of employee training hours without technical details
Correct Answer: Detailed comparison of processes, qualification results, deviations, open items, and recommendations
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com