Quality risk management in technology transfer MCQs With Answer

Quality risk management in technology transfer MCQs With Answer

Quality Risk Management (QRM) is essential for successful technology transfer in pharmaceutical manufacturing. This introduction covers key concepts B.Pharm students must master: risk identification, assessment and mitigation during scale-up, CGMP compliance, ICH Q9 guidance, CQAs, CPPs, control strategy, documentation, validation and comparability. Understanding tools such as FMEA, DoE, risk matrices and root-cause analysis helps ensure product quality and patient safety while minimizing transfer failures and regulatory delays. These MCQs emphasize practical scenarios, regulatory expectations and statistical thinking to deepen your knowledge and prepare you for real-world transfers. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of Quality Risk Management (QRM) during technology transfer?

• To replace validation with ad-hoc testing
• To systematically identify, evaluate and control risks to product quality during transfer
• To reduce documentation required by regulators
• To speed up production regardless of process knowledge

Correct Answer: To systematically identify, evaluate and control risks to product quality during transfer

Q2. Which international guideline specifically provides principles for Quality Risk Management in pharmaceuticals?

• ICH Q8
• ICH Q9
• ICH Q10
• EU Annex 1

Correct Answer: ICH Q9

Q3. Which QRM tool quantitatively ranks failure modes using severity, occurrence and detection?

• Fault Tree Analysis (FTA)
• Failure Mode and Effects Analysis (FMEA)
• Root Cause Analysis (RCA)
• Process Flow Mapping

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q4. During technology transfer, who should lead risk assessments to ensure comprehensive evaluation?

• Quality Assurance only
• Manufacturing only
• Cross-functional team including development, manufacturing, QA and regulatory
• External auditors only

Correct Answer: Cross-functional team including development, manufacturing, QA and regulatory

Q5. What defines a Critical Quality Attribute (CQA) in the context of technology transfer?

• An attribute that has no impact on safety or efficacy
• A physical, chemical or biological property that must be controlled to ensure product quality
• A marketing characteristic preferred by customers
• An equipment specification unrelated to product quality

Correct Answer: A physical, chemical or biological property that must be controlled to ensure product quality

Q6. What is a Critical Process Parameter (CPP)?

• A manufacturing setting unrelated to CQAs
• A process input whose variability impacts one or more CQAs and should be controlled
• A supplier qualification requirement
• A quality attribute measured only after release

Correct Answer: A process input whose variability impacts one or more CQAs and should be controlled

Q7. Which document is most often central to planning and executing a technology transfer?

• Master Production Schedule
• Technology Transfer Protocol or Plan
• Marketing Authorization
• Supplier Invoice

Correct Answer: Technology Transfer Protocol or Plan

Q8. When scaling up a batch process, which parameter is most commonly re-evaluated for its effect on CQAs?

• API molecular structure
• Mixing/agitation and mass/heat transfer parameters
• Country of manufacture
• Packaging color

Correct Answer: Mixing/agitation and mass/heat transfer parameters

Q9. In QRM, what does the ALARP principle mean regarding residual risk?

• Accept risks only if they are above legal limits
• Reduce risks to As Low As Reasonably Practicable
• Ignore residual risks after validation
• Accept any risk after technology transfer is complete

Correct Answer: Reduce risks to As Low As Reasonably Practicable

Q10. Which three factors are multiplied to calculate Risk Priority Number (RPN) in FMEA?

• Severity, Detectability, Cost
• Occurrence, Cost, Time
• Severity, Occurrence, Detection
• Probability, Impact, Speed

Correct Answer: Severity, Occurrence, Detection

Q11. What are the three stages of process validation relevant to technology transfer?

• Design, Qualification, Continued Process Verification
• Installation, Operation, Decommissioning
• Sampling, Analysis, Reporting
• Marketing, Sales, Distribution

Correct Answer: Design, Qualification, Continued Process Verification

Q12. Which element is critical in the transfer dossier to ensure method reproducibility at the receiving site?

• Only batch quantities
• Detailed analytical method SOPs, system suitability and validation data
• Company logo and branding
• Supplier promotional materials

Correct Answer: Detailed analytical method SOPs, system suitability and validation data

Q13. What is the purpose of comparability studies during technology transfer?

• To compare marketing strategies
• To assess whether product quality is maintained after process or site change
• To evaluate packaging aesthetics
• To compare employee headcounts

Correct Answer: To assess whether product quality is maintained after process or site change

Q14. A robust control strategy should primarily manage which of the following?

• Only raw material supply schedules
• Raw materials, CPPs and in-process controls to ensure CQAs
• Only finished product packaging steps
• Only laboratory bookkeeping

Correct Answer: Raw materials, CPPs and in-process controls to ensure CQAs

Q15. Effective risk communication during technology transfer should include which activity?

• Withholding change details from operations
• Timely sharing of risk assessments and mitigation plans with all stakeholders
• Sharing only positive outcomes
• Only communicating after regulatory inspections

Correct Answer: Timely sharing of risk assessments and mitigation plans with all stakeholders

Q16. When is it most appropriate to perform QRM activities in the product lifecycle?

• Only after a product failure occurs
• Throughout the product lifecycle from development through transfer and commercialization
• Only during clinical trials
• Only during final product release

Correct Answer: Throughout the product lifecycle from development through transfer and commercialization

Q17. Which root cause analysis tool visually categorizes potential causes into major headings like Materials, Methods and Machines?

• Pareto Chart
• Ishikawa (Fishbone) Diagram
• Control Chart
• Box Plot

Correct Answer: Ishikawa (Fishbone) Diagram

Q18. Which corrective action is an example of risk mitigation for a process parameter that causes assay variability?

• Ignoring the variability if within limits
• Implementing tighter in-process controls and modifying the process parameter set-point
• Changing product labeling
• Reducing batch size without investigation

Correct Answer: Implementing tighter in-process controls and modifying the process parameter set-point

Q19. Risk ranking often uses which two primary axes in a risk matrix?

• Cost and time
• Likelihood (occurrence) and severity (impact)
• Employee seniority and training hours
• Temperature and humidity

Correct Answer: Likelihood (occurrence) and severity (impact)

Q20. Which statistical metric best reflects process capability while accounting for mean shift relative to specifications?

• Cp
• Cpk
• Standard deviation only
• Mean absolute deviation only

Correct Answer: Cpk

Q21. During scale-up of a wet granulation process, which factor is most likely to change and require re-assessment?

• API pharmacophore
• Granule mixing time and energy input
• Tablet shape code
• Packaging insert language

Correct Answer: Granule mixing time and energy input

Q22. How is change control related to Quality Risk Management in technology transfer?

• Change control is unrelated to QRM
• Change control requires performing QRM to evaluate impact before approval
• QRM replaces change control
• Change control only applies to cosmetics

Correct Answer: Change control requires performing QRM to evaluate impact before approval

Q23. Which outcome is expected after a well-conducted FMEA during transfer?

• Complete elimination of all risks
• Identification and prioritization of failure modes for mitigation
• Replacement of SOPs with verbal instructions
• Reduction in product potency

Correct Answer: Identification and prioritization of failure modes for mitigation

Q24. Why are worst-case conditions selected during validation in technology transfer?

• To demonstrate process robustness and define safe operating boundaries
• To maximize production speed only
• To avoid doing any real testing
• To intentionally produce out-of-spec material

Correct Answer: To demonstrate process robustness and define safe operating boundaries

Q25. What role does knowledge management play in successful technology transfer?

• Documentation of lessons learned, batch records, process understanding and rationale for decisions
• Only archiving marketing brochures
• Replacing training with automated emails
• Maintaining only financial records

Correct Answer: Documentation of lessons learned, batch records, process understanding and rationale for decisions

Q26. Which regulator or guideline explicitly encourages the use of QRM principles in pharmaceutical operations?

• World Health Organization only
• ICH Q9 and most major regulators’ guidance
• Local traffic laws
• Food labeling standards

Correct Answer: ICH Q9 and most major regulators’ guidance

Q27. What is a primary benefit of performing risk assessments early in product development prior to technology transfer?

• Increased regulatory submissions only
• Early identification of critical factors that reduce time, cost and transfer failures
• Elimination of the need for validation
• Delaying process optimization

Correct Answer: Early identification of critical factors that reduce time, cost and transfer failures

Q28. After a successful technology transfer, which activity confirms ongoing reproducibility at the receiving site?

• Market research
• Continued process verification and post-transfer validation
• Changing suppliers frequently
• Reducing sampling plans arbitrarily

Correct Answer: Continued process verification and post-transfer validation

Q29. How does Design of Experiments (DoE) support QRM during technology transfer?

• By randomly changing parameters without documentation
• By identifying CPPs, interactions and robustness of set-points with fewer experiments
• By solely replacing analytical testing
• By increasing batch failure rates intentionally

Correct Answer: By identifying CPPs, interactions and robustness of set-points with fewer experiments

Q30. On what basis should risk acceptance criteria be defined for technology transfer decisions?

• Based solely on production deadlines
• Based on patient safety, product quality and regulatory expectations
• Based on marketing preferences
• Based on the cheapest available option

Correct Answer: Based on patient safety, product quality and regulatory expectations

G S Sachin

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