WHO guidelines for technology transfer – terminology and objectives MCQs With Answer

Introduction: The WHO guidelines for technology transfer outline clear terminology and objectives to ensure successful transfer of pharmaceutical manufacturing processes, analytical methods, and quality systems. For B.Pharm students, understanding key concepts—such as donor and recipient, technology package, tech transfer plan, knowledge transfer, capacity building, validation, documentation, GMP compliance, regulatory requirements, and quality assurance—is essential. These guidelines aim to maintain product quality, ensure comparability, mitigate risks during scale-up, protect intellectual property, and support regulatory approval. Grasping WHO terminology and objectives helps future pharmacists participate in transfers, audits, and regulatory submissions with confidence. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the best definition of technology transfer according to WHO concepts?

• The planned process of transferring product and process knowledge from a donor to a recipient to enable reliable production at a new site
• The sale of manufacturing equipment from one company to another
• The outsourcing of packaging services to a contract manufacturer
• The clinical trial phase focused on new drug candidates

Correct Answer: The planned process of transferring product and process knowledge from a donor to a recipient to enable reliable production at a new site

Q2. Which term refers to the detailed information set that describes a product, process, and quality attributes for transfer?

• Regulatory dossier
• Technology package
• Master formula
• Clinical protocol

Correct Answer: Technology package

Q3. One primary objective of WHO technology transfer guidance is:

• Maximizing profit margins for the donor site
• Ensuring maintenance of product quality and safety during transfer
• Avoiding documentation to speed up transfer
• Shifting regulatory responsibility entirely to the recipient

Correct Answer: Ensuring maintenance of product quality and safety during transfer

Q4. Who is typically responsible for providing the technology package during a transfer?

• The regulatory authority
• The donor (originating) site or organization
• The packaging supplier
• The clinical investigator

Correct Answer: The donor (originating) site or organization

Q5. Which document outlines roles, timelines, acceptance criteria, and activities for a transfer?

• Quality manual
• Technology transfer plan
• Stability protocol
• Clinical study report

Correct Answer: Technology transfer plan

Q6. In WHO terminology, the organization receiving the product knowledge is called the:

• Donor
• Recipient
• Sponsor
• Regulatory liaison

Correct Answer: Recipient

Q7. A core objective when transferring analytical methods is to:

• Change the method to reduce testing time without validation
• Ensure method transfer verifies suitability and reproducibility at the receiving lab
• Replace all reference standards with new ones
• Only perform testing at the donor site permanently

Correct Answer: Ensure method transfer verifies suitability and reproducibility at the receiving lab

Q8. Which activity is essential during process transfer to confirm equivalence between sites?

• Technology readiness assessment only
• Performance of comparative validation or qualification batches
• Immediate launch of commercial production
• Ignoring critical process parameters

Correct Answer: Performance of comparative validation or qualification batches

Q9. Which regulatory concept must be considered during technology transfer?

• Post-transfer regulatory notifications and approvals as required by authorities
• That no regulatory interactions are necessary
• Only internal approvals matter
• Regulatory requirements are identical in every country

Correct Answer: Post-transfer regulatory notifications and approvals as required by authorities

Q10. In WHO guidance, risk assessment during transfer primarily addresses:

• Financial investment returns
• Potential impacts on product quality, safety, and supply continuity
• Marketing strategies
• Patent expiration dates

Correct Answer: Potential impacts on product quality, safety, and supply continuity

Q11. Which element is NOT typically part of a technology package?

• Detailed process parameters and control strategy
• Analytical methods and validation data
• Clinical trial participants’ names
• Specifications and stability data

Correct Answer: Clinical trial participants’ names

Q12. Capacity building in technology transfer refers to:

• Training of personnel, strengthening facilities, and transferring know-how
• Only buying new equipment
• Outsourcing all activities to third parties
• Marketing training for sales staff

Correct Answer: Training of personnel, strengthening facilities, and transferring know-how

Q13. Which quality concept ensures that transferred processes consistently produce product meeting predefined specifications?

• Good manufacturing practice (GMP)
• Patent law
• Market exclusivity
• Advertising standards

Correct Answer: Good manufacturing practice (GMP)

Q14. During technology transfer, intellectual property issues should be managed primarily through:

• Informal verbal agreements
• Clear contractual agreements and confidentiality arrangements
• Publicly posting all technical details online
• Assuming IP is automatically transferred

Correct Answer: Clear contractual agreements and confidentiality arrangements

Q15. Which metric is commonly used to judge success of a technology transfer?

• Number of emails exchanged
• Achievement of predefined acceptance criteria for transferred batches and methods
• Size of donor company
• Duration of product development phase

Correct Answer: Achievement of predefined acceptance criteria for transferred batches and methods

Q16. Analytical method transfer reports should document:

• Only the names of analysts
• Comparative data, acceptance criteria, method conditions, and deviations
• Marketing plans for the product
• Employee personal opinions

Correct Answer: Comparative data, acceptance criteria, method conditions, and deviations

Q17. Process validation after transfer usually requires:

• No production runs
• Prospective validation or concurrent validation with representative batches
• Only laboratory small-scale experiments
• Validation completed by donors only

Correct Answer: Prospective validation or concurrent validation with representative batches

Q18. A successful knowledge transfer involves:

• Only sending SOP documents without training
• Structured training, site visits, demonstrations, and continued support
• Replacing staff at the recipient site
• Delaying documentation until after production

Correct Answer: Structured training, site visits, demonstrations, and continued support

Q19. Which WHO objective focuses on supply chain continuity during transfer?

• Minimizing documentation
• Ensuring uninterrupted supply and timely availability of quality products
• Maximizing donor profits
• Reducing workforce training

Correct Answer: Ensuring uninterrupted supply and timely availability of quality products

Q20. Change control in the context of transfer is important because:

• It helps manage planned modifications and assesses impact on product quality
• It eliminates the need for approvals
• It accelerates undocumented changes
• It is irrelevant post-transfer

Correct Answer: It helps manage planned modifications and assesses impact on product quality

Q21. Which party typically performs final release testing after a successful transfer and initial validation?

• The donor only, forever
• The recipient site, once qualified and approved
• The regulatory authority’s laboratory
• The marketing department

Correct Answer: The recipient site, once qualified and approved

Q22. Documentation traceability during transfer ensures:

• That all key decisions, data, and approvals are recorded and can be audited
• Records are deleted after transfer
• Only numerical data is kept
• That verbal instructions are sufficient

Correct Answer: That all key decisions, data, and approvals are recorded and can be audited

Q23. Which is a common challenge specifically for international technology transfers?

• Uniform regulatory requirements across countries
• Differences in regulatory expectations, GMP standards, and documentation formats
• Absence of language barriers
• Simple logistics with no customs issues

Correct Answer: Differences in regulatory expectations, GMP standards, and documentation formats

Q24. The role of quality assurance (QA) in transfer is to:

• Only approve budgets
• Define quality requirements, review documentation, and ensure compliance throughout transfer
• Conduct marketing surveys
• Operate production equipment daily

Correct Answer: Define quality requirements, review documentation, and ensure compliance throughout transfer

Q25. Which activity helps verify that critical process parameters are under control at the recipient site?

• Random guessing of set points
• Process characterization and monitoring during qualification batches
• Only checking final product appearance
• Delaying monitoring until after product launch

Correct Answer: Process characterization and monitoring during qualification batches

Q26. For transfer of aseptic manufacturing, WHO guidance emphasizes:

• Ignoring environmental monitoring
• Comprehensive facility qualification, personnel training, environmental monitoring, and sterility assurance
• Performing operations without validated cleaning
• Skipping validation to save time

Correct Answer: Comprehensive facility qualification, personnel training, environmental monitoring, and sterility assurance

Q27. Which factor is important when transferring formulation composition between sites?

• Only the color of the product
• Excipients source, material attributes, and compatibility with process
• Marketing claims
• Distribution channels

Correct Answer: Excipients source, material attributes, and compatibility with process

Q28. The WHO recommends that technology transfer agreements should include:

• Clear scope, responsibilities, timelines, confidentiality, and IP terms
• Only informal handshake agreements
• Exclusion of quality clauses
• Open public access to proprietary methods

Correct Answer: Clear scope, responsibilities, timelines, confidentiality, and IP terms

Q29. During transfer, stability data must be reviewed to ensure:

• That the product has a valid shelf-life and appropriate storage conditions post-transfer
• Only short-term marketing uses
• That stability is irrelevant after transfer
• That product color remains unchanged

Correct Answer: That the product has a valid shelf-life and appropriate storage conditions post-transfer

Q30. A technology readiness assessment helps determine:

• Whether a product is ready to be marketed without quality checks
• If the process, facility, and personnel are prepared for transfer and scale-up
• Only the branding strategy
• That regulatory approval is automatic

Correct Answer: If the process, facility, and personnel are prepared for transfer and scale-up

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