Introduction: Technology transfer for APIs, excipients and finished products is a structured process that moves a drug substance or formulation from development to manufacturing scale while ensuring product quality, safety and regulatory compliance. Key elements include characterization of critical quality attributes (CQAs), identification of critical process parameters (CPPs), analytical method transfer, stability studies, scale-up considerations, documentation (TTA, master formula, batch records) and risk assessment. Understanding comparability, process validation and manufacturing controls is vital for successful commercialization and inspections. This topic links formulation science, process engineering and regulatory requirements to ensure reproducible, compliant production. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary objective of technology transfer in pharmaceutical manufacturing?
- To increase marketing budget
- To move a process from development to manufacturing ensuring consistent quality
- To change the active pharmaceutical ingredient
- To redesign packaging for aesthetics
Correct Answer: To move a process from development to manufacturing ensuring consistent quality
Q2. Which document typically formalizes responsibilities and deliverables between sending and receiving units during transfer?
- Standard Operating Procedure (SOP)
- Technology Transfer Agreement (TTA)
- Certificate of Analysis (CoA)
- Patient Information Leaflet
Correct Answer: Technology Transfer Agreement (TTA)
Q3. Which of the following best defines a Critical Quality Attribute (CQA)?
- An attribute unrelated to safety or efficacy
- A physical, chemical or biological property that should be within limits to ensure product quality
- A marketing specification for shelf display
- An employee performance metric
Correct Answer: A physical, chemical or biological property that should be within limits to ensure product quality
Q4. Critical Process Parameters (CPPs) are important because they directly affect:
- Employee attendance
- Critical Quality Attributes (CQAs)
- Advertising reach
- Office layout
Correct Answer: Critical Quality Attributes (CQAs)
Q5. During API technology transfer, which characterization is essential for understanding impurities and polymorphism?
- Market analysis
- X-ray powder diffraction and HPLC impurity profiling
- Graphic design review
- Tablet coating color test
Correct Answer: X-ray powder diffraction and HPLC impurity profiling
Q6. Which scale is primarily used to demonstrate process scalability before commercial batches?
- Analytical micro-scale
- Pilot scale
- Retail scale
- Home kitchen scale
Correct Answer: Pilot scale
Q7. What is comparability in the context of technology transfer?
- Comparing marketing strategies
- Demonstrating that product quality is equivalent pre- and post-transfer
- Comparing salaries across sites
- Comparing tablet colors only
Correct Answer: Demonstrating that product quality is equivalent pre- and post-transfer
Q8. Which regulatory guideline is most relevant for pharmaceutical development and offers principles for quality by design?
- ICH Q8
- ISO 9001
- GMP Annex 1
- ICH Q3A only
Correct Answer: ICH Q8
Q9. Analytical method transfer focuses on which main objective?
- Transferring marketing content
- Ensuring method performance is reproducible at the receiving lab
- Reducing method complexity regardless of accuracy
- Changing the method developer
Correct Answer: Ensuring method performance is reproducible at the receiving lab
Q10. Which test is essential for finished product release after technology transfer?
- Color preference test
- Assay and dissolution testing
- Employee satisfaction survey
- Packaging QR code creation
Correct Answer: Assay and dissolution testing
Q11. Which element is NOT typically part of a technology transfer master file?
- Process flow diagrams
- Formulation composition
- Marketing campaign details
- Analytical methods and specifications
Correct Answer: Marketing campaign details
Q12. Why are validation batches important in the transfer process?
- They test commercial marketing
- They demonstrate reproducibility at intended commercial scale
- They are used to train sales reps
- They reduce the need for documentation
Correct Answer: They demonstrate reproducibility at intended commercial scale
Q13. Risk assessment tools in transfer commonly include:
- Failure Mode and Effects Analysis (FMEA)
- Social media analytics
- Graphic design testing
- Employee background checks
Correct Answer: Failure Mode and Effects Analysis (FMEA)
Q14. Which excipient property critically affects tablet disintegration during scale-up?
- Color
- Disintegrant concentration and particle size
- Company logo
- Packaging label font
Correct Answer: Disintegrant concentration and particle size
Q15. During transfer, what is the significance of establishing acceptance criteria for CQAs?
- To define commercial pricing
- To set limits that ensure product safety and efficacy
- To determine employee bonuses
- To choose suppliers arbitrarily
Correct Answer: To set limits that ensure product safety and efficacy
Q16. A site change in manufacturing necessitates focus on which regulatory submission element?
- New product logo
- Comparability data and regulatory notification or amendment
- Change in HR policies
- Different office furniture
Correct Answer: Comparability data and regulatory notification or amendment
Q17. Which factor is crucial when scaling up API crystallization from lab to pilot scale?
- Marketing channel selection
- Mixing energy, cooling rate and solvent composition
- Office cleaning schedule
- Color of lab coats
Correct Answer: Mixing energy, cooling rate and solvent composition
Q18. What role does stability data play in technology transfer for finished products?
- It determines labeling font size
- It supports shelf-life and storage conditions at the new site
- It measures employee stability
- It replaces analytical testing
Correct Answer: It supports shelf-life and storage conditions at the new site
Q19. Which is an example of a process-related impurity that must be controlled during API transfer?
- Tablet coating pigment
- Residual solvents and synthetic by-products
- Employee dietary preferences
- Promotional slogan
Correct Answer: Residual solvents and synthetic by-products
Q20. A master batch record should include which of the following?
- Batch-specific production instructions, materials, equipment and in-process checks
- Only the marketing approach
- Employee personal data
- Customer feedback forms
Correct Answer: Batch-specific production instructions, materials, equipment and in-process checks
Q21. During excipient transfer, why is supplier qualification important?
- To ensure timely advertising
- To confirm consistent quality, traceability and compliance with specifications
- To increase shipping costs
- To change product color
Correct Answer: To confirm consistent quality, traceability and compliance with specifications
Q22. Which metric helps determine whether a process change is significant enough to require regulatory notification?
- Impact on CQAs and clinical performance
- Impact on cafeteria menu
- Change in office hours
- Change in web domain
Correct Answer: Impact on CQAs and clinical performance
Q23. What is the typical purpose of a technology transfer checklist?
- To decorate the lab
- To ensure all technical, quality and documentation items are addressed
- To calculate marketing ROI
- To plan the annual party
Correct Answer: To ensure all technical, quality and documentation items are addressed
Q24. In-process controls (IPCs) are used to:
- Verify marketing effectiveness
- Monitor critical steps to ensure the process stays within defined limits
- Record employee birthdays
- Design the product logo
Correct Answer: Monitor critical steps to ensure the process stays within defined limits
Q25. Which validation concept demonstrates a process remains in a state of control over time?
- Continuous process verification
- One-time installation qualification only
- Promotional validation
- Logo consistency check
Correct Answer: Continuous process verification
Q26. For finished product transfer, dissolution method changes require:
- No documentation
- Demonstration of equivalence or validation of the new method
- Only a marketing announcement
- Change in packaging color
Correct Answer: Demonstration of equivalence or validation of the new method
Q27. Which assessment assigns criticality to process steps and helps prioritize control efforts?
- Criticality assessment or risk ranking
- Employee ranking
- Social media scoring
- Market segmentation
Correct Answer: Criticality assessment or risk ranking
Q28. What is the advantage of using quality by design (QbD) principles in transfer?
- Reduces need for any testing
- Provides systematic understanding of process and robust design space for control
- Eliminates regulatory oversight
- Guarantees zero impurities
Correct Answer: Provides systematic understanding of process and robust design space for control
Q29. Which parameter is commonly included in acceptance criteria for excipient lots?
- Supplier logo color
- Particle size distribution and moisture content
- Shipping cost
- Number of employees at supplier
Correct Answer: Particle size distribution and moisture content
Q30. After successful technology transfer, the receiving site should be able to:
- Only replicate packaging
- Consistently produce product meeting predefined CQAs and specifications
- Reduce all testing indefinitely
- Change the active ingredient at will
Correct Answer: Consistently produce product meeting predefined CQAs and specifications
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