Technology transfer plan and exhibit batches MCQs With Answer

Introduction: Technology transfer plan and exhibit batches MCQs With Answer is designed for M. Pharm students to deepen understanding of the critical steps involved in transferring a drug product from development to manufacturing. This short quiz collection explains planning, documentation, responsibilities, analytical and process transfers, exhibit batch purpose, scale-up considerations, validation links, and regulatory expectations. Each question targets practical decision-making and regulatory science—helpful for viva, exams, or real-world project work. The MCQs emphasize risk assessment, comparability, analytical method transfer, equipment and cleaning considerations, and the role of exhibit batches in establishing control and stability data for submissions.

Q1. What is the primary purpose of a technology transfer plan in pharmaceutical development?

• To establish a marketing and commercial launch timeline
• To define clinical trial design only
• To ensure reproducible, controlled manufacturing of the product at the receiving site by documenting process, equipment, and controls
• To negotiate raw material prices with vendors

Correct Answer: To ensure reproducible, controlled manufacturing of the product at the receiving site by documenting process, equipment, and controls

Q2. Which statement best describes an exhibit batch in the context of technology transfer?

• A laboratory-scale exploratory batch produced to test new formulations
• Batches manufactured at the receiving site to demonstrate the transferred process and to generate data (manufacturing, analytical, stability) supportive of subsequent validation and regulatory filing
• Commercial production batches released directly to market
• Batches produced only for marketing samples and exhibitions

Correct Answer: Batches manufactured at the receiving site to demonstrate the transferred process and to generate data (manufacturing, analytical, stability) supportive of subsequent validation and regulatory filing

Q3. How many exhibit batches are typically recommended to demonstrate process performance prior to full-scale validation?

• One exhibit batch is always sufficient
• Two to three exhibit batches to demonstrate reproducibility and identify issues
• Five consecutive batches are required before any validation
• Ten batches to build statistical power

Correct Answer: Two to three exhibit batches to demonstrate reproducibility and identify issues

Q4. Which document governs the formal transfer of analytical methods between labs/sites?

• Analytical method transfer protocol (method transfer plan)
• Validation master plan (VMP)
• Good Distribution Practices (GDP) manual
• Clinical study protocol

Correct Answer: Analytical method transfer protocol (method transfer plan)

Q5. What is the main responsibility of the sending unit (originator) during technology transfer?

• To manage commercial distribution and sales
• To provide complete process knowledge, training, demonstration batches, and critical documentation to the receiving unit
• To prepare patient information leaflets
• To perform only stability studies and nothing else

Correct Answer: To provide complete process knowledge, training, demonstration batches, and critical documentation to the receiving unit

Q6. Which of the following is an example of a Critical Quality Attribute (CQA) for a solid oral dosage form?

• Mixing time as set on the blender (a process parameter)
• Equipment serial number
• Drug potency (assay) and related impurities
• Supplier’s marketing claims

Correct Answer: Drug potency (assay) and related impurities

Q7. On what basis should acceptance criteria for exhibit batches be defined?

• Arbitrary targets set by the production manager
• Regulatory guidance only, ignoring historical product performance
• Product specifications, historical development data, scientific rationale and risk assessment
• Marketing preferences for appearance and packaging only

Correct Answer: Product specifications, historical development data, scientific rationale and risk assessment

Q8. Which risk assessment tool is most commonly used during technology transfer to identify potential failure modes?

• SWOT analysis
• Failure Mode and Effects Analysis (FMEA)
• Kaplan-Meier survival analysis
• Pareto chart only

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q9. Which process capability index is most relevant to assess if a transferred process consistently meets specifications?

• R-squared
• Cpk (process capability index)
• P-value
• Median absolute deviation

Correct Answer: Cpk (process capability index)

Q10. When transferring a process to new equipment at the receiving site, which factor is most critical to evaluate?

• Color of the new equipment
• Operator badge numbers
• Equipment equivalence, scale factors, and impact on critical process parameters
• Proximity to the marketing office

Correct Answer: Equipment equivalence, scale factors, and impact on critical process parameters

Q11. What stability data are typically expected from exhibit batches submitted with a regulatory filing?

• No stability data are required for exhibit batches
• Full 36-month long-term data only
• Sufficient initial stability data (accelerated and short-term long-term) to support the filing, with a commitment for ongoing stability monitoring
• Only in-use stability at room temperature

Correct Answer: Sufficient initial stability data (accelerated and short-term long-term) to support the filing, with a commitment for ongoing stability monitoring

Q12. Which criteria must be demonstrated during analytical method transfer acceptance?

• Only linearity is necessary
• Only cost-effectiveness and speed
• Accuracy, precision, specificity, and robustness within predefined limits
• Only that the instrument can run the method

Correct Answer: Accuracy, precision, specificity, and robustness within predefined limits

Q13. During technology transfer, what is required regarding cleaning validation?

• Cleaning validation is not needed for transferred processes
• Demonstration that cleaning procedures meet established limits using worst-case products and surfaces, with appropriate sampling and analytical methods
• Only visual inspection of equipment is sufficient
• Cleaning validation only after 100 commercial batches

Correct Answer: Demonstration that cleaning procedures meet established limits using worst-case products and surfaces, with appropriate sampling and analytical methods

Q14. What should a technology transfer report typically contain?

• A short marketing brief and sales forecast
• Only the master formula with no supporting data
• A comprehensive summary including process description, batch records, deviations, analytical data, training records, comparability results and recommendations for validation
• Only raw analytical chromatograms without interpretation

Correct Answer: A comprehensive summary including process description, batch records, deviations, analytical data, training records, comparability results and recommendations for validation

Q15. If an excipient supplier changes during transfer, what is the appropriate immediate action?

• Proceed without testing because excipients are inert
• Initiate a comparability assessment and risk analysis; perform specific qualification testing as required
• Recall all product already produced
• Only update the label and document the change

Correct Answer: Initiate a comparability assessment and risk analysis; perform specific qualification testing as required

Q16. One of the principal uses of exhibit batches is to:

• Create promotional product samples for conferences
• Demonstrate process reproducibility at the receiving site and generate data for validation and regulatory submission
• Test alternative packaging designs only
• Replace clinical batches in all cases

Correct Answer: Demonstrate process reproducibility at the receiving site and generate data for validation and regulatory submission

Q17. In the CTD format, which module contains manufacturing site information and process validation/technology transfer data?

• Module 1
• Module 2 (summaries only)
• Module 3 (Quality: manufacture, controls, validation)
• Module 5 (clinical study reports)

Correct Answer: Module 3 (Quality: manufacture, controls, validation)

Q18. Typical KPIs monitored during a technology transfer include:

• Only the number of operators trained
• Yield, product assay, impurity levels, and batch rejection rate
• Only the marketing approval date
• Office supply expenditures

Correct Answer: Yield, product assay, impurity levels, and batch rejection rate

Q19. Which set of criteria best describes successful completion of a technology transfer?

• Only obtaining a signed transfer agreement
• Meeting predefined product specifications, demonstrating process capability, completing required documentation, and ensuring staff training and equipment readiness
• Only running a single exhibit batch
• Only updating the regulatory dossier without any on-site verification

Correct Answer: Meeting predefined product specifications, demonstrating process capability, completing required documentation, and ensuring staff training and equipment readiness

Q20. If an analytical method produces out-of-specification (OOS) results during transfer, what is the correct course of action?

• Discard the data and ignore the results
• Investigate the OOS result with root cause analysis, perform necessary corrective actions, and re-evaluate/re-validate the method if required
• Immediately stop the project permanently
• Change the specification to accept the result

Correct Answer: Investigate the OOS result with root cause analysis, perform necessary corrective actions, and re-evaluate/re-validate the method if required

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