Technology transfer protocol and documentation MCQs With Answer

Introduction

The technology transfer protocol and documentation are central to successful pharmaceutical product handover from development to manufacturing. This topic covers preparation of a robust Technology Transfer Protocol (TTP), essential technology transfer documentation, critical quality attributes (CQA), critical process parameters (CPP), analytical method transfer, scale-up challenges, process validation, batch records, equipment qualification, risk assessment (FMEA), and regulatory expectations (ICH Q8/Q9/Q10). B. Pharm students must master checklists, acceptance criteria, change control, and post-transfer monitoring to ensure consistent product quality and compliance. Clear documentation and knowledge transfer reduce deviations, support CMC filings, and facilitate audits. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of a Technology Transfer Protocol (TTP)?

• To define marketing strategies for a new drug product
• To document the stepwise plan for transferring manufacturing and analytical methods between sites
• To replace standard operating procedures permanently
• To establish the final product label design

Correct Answer: To document the stepwise plan for transferring manufacturing and analytical methods between sites

Q2. Which document typically contains acceptance criteria for transferred batches during tech transfer?

• Marketing authorisation dossier
• Technology Transfer Protocol (TTP)
• Employee training records
• Environmental monitoring logs

Correct Answer: Technology Transfer Protocol (TTP)

Q3. In technology transfer, what does CQA stand for and why is it important?

• Critical Quality Attributes; they define the physical, chemical, biological characteristics that must be controlled
• Commercial Quality Assessment; it measures market acceptance
• Certified Quality Audit; it is a regulatory inspection report
• Controlled Quantity Adjustment; it sets manufacturing batch sizes

Correct Answer: Critical Quality Attributes; they define the physical, chemical, biological characteristics that must be controlled

Q4. Which guideline is most relevant for pharmaceutical development and quality by design during tech transfer?

• ICH Q8
• ICH E2
• USP General Chapter
• ISO 9001

Correct Answer: ICH Q8

Q5. What is the role of Critical Process Parameters (CPP) in a tech transfer?

• They describe packaging artwork requirements
• They are process variables that impact CQAs and must be controlled during transfer
• They list suppliers for raw materials
• They determine shipping routes for finished goods

Correct Answer: They are process variables that impact CQAs and must be controlled during transfer

Q6. Which of the following is an essential element of technology transfer documentation for analytical method transfer?

• Method transfer plan, validation data, acceptance criteria, and training records
• Company annual financial report
• Marketing brochures for the product
• Employee personal CVs

Correct Answer: Method transfer plan, validation data, acceptance criteria, and training records

Q7. During scale-up, which parameter is most commonly adjusted to maintain similar mixing characteristics?

• Batch numbering scheme
• Impeller tip speed or power per unit volume
• Storage temperature for finished product
• Label expiry date

Correct Answer: Impeller tip speed or power per unit volume

Q8. What is the purpose of a Tech Transfer Report?

• To record promotional strategies for the product
• To summarize transfer activities, results, deviations, and recommendations for commercial manufacture
• To list all employees involved in manufacturing
• To provide clinical trial patient data

Correct Answer: To summarize transfer activities, results, deviations, and recommendations for commercial manufacture

Q9. Which risk assessment tool is frequently used during technology transfer to prioritize risks to product quality?

• SWOT analysis
• Failure Mode and Effects Analysis (FMEA)
• PESTLE analysis
• Monte Carlo simulation

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q10. Which phase typically follows successful pilot-scale transfers before full commercial manufacturing?

• Stability chamber qualification
• Process validation (routine commercial batches)
• Marketing launch
• Product recall simulation

Correct Answer: Process validation (routine commercial batches)

Q11. What is a key regulatory expectation for technology transfer documentation in CMC submissions?

• Detailed QA salaries
• Clear description of manufacturing process, controls, validation, and comparability data
• Advertising budget
• Patient testimonials

Correct Answer: Clear description of manufacturing process, controls, validation, and comparability data

Q12. When transferring an analytical method, which parameter indicates precision?

• Retention time
• Repeatability and intermediate precision (RSD values)
• Appearance of the instrument
• Column brand

Correct Answer: Repeatability and intermediate precision (RSD values)

Q13. What is the importance of equipment qualification in tech transfer?

• It documents that equipment performs as intended and is suitable for the transferred process
• It assigns equipment to marketing
• It provides incentives for operators
• It replaces method validation

Correct Answer: It documents that equipment performs as intended and is suitable for the transferred process

Q14. Which document contains stepwise manufacturing instructions and is often included in transfer packs?

• Master Batch Record (MBR) or Standard Batch Manufacturing Record
• Customer complaint log
• Financial forecast
• Supplier marketing materials

Correct Answer: Master Batch Record (MBR) or Standard Batch Manufacturing Record

Q15. Why is post-transfer monitoring important after a technology transfer?

• To track marketing reach
• To ensure process performance stability, detect trends, and implement improvements
• To register new patents
• To change brand names frequently

Correct Answer: To ensure process performance stability, detect trends, and implement improvements

Q16. Which section of a TTP defines roles and responsibilities during the transfer?

• Transfer governance or responsibilities section
• Financial appendix
• Environmental policy
• Marketing plan

Correct Answer: Transfer governance or responsibilities section

Q17. Which is a critical element of comparability assessment after scale-up or site change?

• Comparing product color only
• Analytical comparability of CQAs and demonstration of similar safety/efficacy characteristics
• Changing the active ingredient
• Altering the brand logo

Correct Answer: Analytical comparability of CQAs and demonstration of similar safety/efficacy characteristics

Q18. What is the first step when planning a technology transfer?

• Ordering commercial labels
• Conducting a detailed gap assessment between sending and receiving sites
• Hiring sales representatives
• Publishing a press release

Correct Answer: Conducting a detailed gap assessment between sending and receiving sites

Q19. During method transfer, which parameter measures accuracy?

• System suitability only
• Recovery studies comparing measured vs true concentration
• Packaging material type
• Operator handwriting

Correct Answer: Recovery studies comparing measured vs true concentration

Q20. Which change management tool ensures controlled changes after transfer?

• Change control system with impact assessment and approvals
• Unrecorded verbal approvals
• Spontaneous process adjustments
• Marketing-oriented memos

Correct Answer: Change control system with impact assessment and approvals

Q21. What should a Technology Transfer Checklist typically include?

• Items such as process steps, equipment list, materials, analytical methods, training, acceptance criteria, and timelines
• Only marketing contact numbers
• Only the CEO signature
• Only packaging sketches

Correct Answer: Items such as process steps, equipment list, materials, analytical methods, training, acceptance criteria, and timelines

Q22. Which stability consideration is important during tech transfer?

• Comparative stability data for product manufactured at sending and receiving sites under ICH conditions
• Stability of the company logo
• Stability of office furniture
• Stability of marketing slogans

Correct Answer: Comparative stability data for product manufactured at sending and receiving sites under ICH conditions

Q23. What role does training play in technology transfer?

• It ensures receiving site personnel understand the process, SOPs, safety, and analytical methods
• It allocates marketing budgets
• It selects distribution channels
• It determines packaging color

Correct Answer: It ensures receiving site personnel understand the process, SOPs, safety, and analytical methods

Q24. Which metric is useful for evaluating transfer success during initial commercial batches?

• Number of promotional events
• Batch-to-batch variability of CQAs and conformance to acceptance criteria
• Employee attendance at social events
• Size of the company logo

Correct Answer: Batch-to-batch variability of CQAs and conformance to acceptance criteria

Q25. When transferring a sterile product, which additional documentation is critical?

• Aseptic process validation, environmental monitoring data, and sterility assurance records
• Retail pricing lists
• Advertising copy
• Travel reimbursement policies

Correct Answer: Aseptic process validation, environmental monitoring data, and sterility assurance records

Q26. How should raw material specifications be handled during tech transfer?

• Maintain or harmonize supplier, material specifications, and acceptance criteria with documented justification
• Replace all raw materials with cheaper alternatives without testing
• Eliminate specification limits entirely
• Only use supplier verbal assurances

Correct Answer: Maintain or harmonize supplier, material specifications, and acceptance criteria with documented justification

Q27. Which aspect of documentation supports reproducibility after tech transfer?

• Clear, detailed SOPs, batch records, process parameter ranges, and analytical methods
• Colorful presentation slides
• Personal notes hidden in desk drawers
• Unstructured emails only

Correct Answer: Clear, detailed SOPs, batch records, process parameter ranges, and analytical methods

Q28. What is the significance of comparability protocols during site transfer?

• They define experiments and acceptance criteria to demonstrate product equivalence between sites
• They set advertising strategies
• They determine pricing policies
• They list employee birthdays

Correct Answer: They define experiments and acceptance criteria to demonstrate product equivalence between sites

Q29. Which regulatory dossiers require documentation of technology transfer activities?

• Chemistry, Manufacturing and Controls (CMC) section of regulatory submissions
• Only the marketing brochure
• Sales authorization forms
• Human resource policies

Correct Answer: Chemistry, Manufacturing and Controls (CMC) section of regulatory submissions

Q30. What is a common indicator that an analytical method transfer has failed?

• Consistent out-of-specification (OOS) results, poor precision, or unacceptable bias compared with the sending lab
• Increased number of marketing emails
• Changes in company logo color
• Higher staff cafeteria usage

Correct Answer: Consistent out-of-specification (OOS) results, poor precision, or unacceptable bias compared with the sending lab

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