Introduction: Transfer of process, packaging and cleaning from R&D to production is a critical phase in pharmaceutical development that ensures safe, scalable, and compliant manufacturing. This technology transfer covers process transfer, scale-up, analytical method transfer, equipment qualification (IQ/OQ/PQ), cleaning validation, packaging validation, container-closure integrity, GMP documentation, and process validation. Key concepts include critical quality attributes (CQAs), critical process parameters (CPPs), risk assessment, design of experiments (DoE), material and personnel flow, cross-contamination control, and regulatory expectations. Mastering transfer planning, protocols, and validation strategies reduces batch failures and regulatory risk. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary objective of technology transfer from R&D to production?
- To increase marketing activities
- To enable scalable, reproducible manufacturing while preserving product quality
- To reduce research funding
- To change the product formulation for new markets
Correct Answer: To enable scalable, reproducible manufacturing while preserving product quality
Q2. Which document typically outlines the activities, responsibilities and acceptance criteria for a process transfer?
- Batch Manufacturing Record
- Technology Transfer Plan
- Marketing Authorization Application
- Stability Protocol
Correct Answer: Technology Transfer Plan
Q3. Critical Quality Attributes (CQAs) are best described as:
- Attributes that define packaging aesthetics
- Properties that must be controlled to ensure product safety and efficacy
- Employee performance metrics
- Marketing KPIs
Correct Answer: Properties that must be controlled to ensure product safety and efficacy
Q4. During scale-up, which factor is most important to maintain similarity between lab and plant?
- Using the same brand of reagents
- Maintaining equivalent critical process parameters and unit operations
- Hiring more operators
- Changing the formulation concentration
Correct Answer: Maintaining equivalent critical process parameters and unit operations
Q5. Which qualification phase verifies that equipment functions as intended under simulated conditions?
- IQ (Installation Qualification)
- OQ (Operational Qualification)
- PQ (Performance Qualification)
- Design Qualification
Correct Answer: OQ (Operational Qualification)
Q6. What is the main goal of cleaning validation during transfer?
- To establish cleaning SOPs without testing
- To demonstrate the cleaning procedure consistently reduces residues to acceptable limits
- To speed up production cycles regardless of cleanliness
- To validate packaging seal strength
Correct Answer: To demonstrate the cleaning procedure consistently reduces residues to acceptable limits
Q7. Which approach helps identify worst-case conditions for cleaning validation?
- Selecting the smallest batch size
- Risk assessment based on solubility, toxicity, and formulation difficulty
- Using only inert compounds
- Random selection of production days
Correct Answer: Risk assessment based on solubility, toxicity, and formulation difficulty
Q8. Analytical method transfer aims to:
- Replace the method with a new unvalidated test
- Demonstrate the receiving lab can perform the validated method with equivalent results
- Reduce the number of tests to save time
- Change acceptance limits
Correct Answer: Demonstrate the receiving lab can perform the validated method with equivalent results
Q9. Which study assesses the physical integrity of packaging and container-closure systems?
- Cleaning Validation
- Container Closure Integrity (CCI) testing
- Stability indicating assay
- Environmental monitoring
Correct Answer: Container Closure Integrity (CCI) testing
Q10. In-process controls (IPCs) are used to:
- Monitor process parameters and attributes during manufacturing
- Replace final release testing
- Perform marketing checks
- Determine employee salaries
Correct Answer: Monitor process parameters and attributes during manufacturing
Q11. What does PQ verify in equipment qualification?
- That equipment has been schematically designed
- That equipment consistently produces quality product under routine production conditions
- That equipment is delivered on time
- That equipment can be cleaned without documentation
Correct Answer: That equipment consistently produces quality product under routine production conditions
Q12. Which parameter is typically NOT a Critical Process Parameter (CPP)?
- Mixing time affecting content uniformity
- Drying temperature affecting residual moisture
- Operator’s favorite color
- Compression force affecting tablet hardness
Correct Answer: Operator’s favorite color
Q13. What is the purpose of a bridging study during technology transfer?
- To bridge communication gaps between HR and production
- To link small-scale data to full-scale production when changes exist
- To eliminate validation requirements
- To transfer marketing materials
Correct Answer: To link small-scale data to full-scale production when changes exist
Q14. Which sampling method is commonly used to verify surface cleanliness after cleaning?
- Visual inspection only
- Swab sampling and rinse sampling
- Thermal imaging
- pH paper only
Correct Answer: Swab sampling and rinse sampling
Q15. During packaging transfer, what is a key regulatory requirement?
- Changing label content without approval
- Ensuring label accuracy, traceability and compliance with marketing authorization
- Using lower quality packaging to reduce costs
- Removing tamper-evident features
Correct Answer: Ensuring label accuracy, traceability and compliance with marketing authorization
Q16. Which concept helps to control cross-contamination risk during transfer?
- Shared personnel and equipment without segregation
- Dedicated equipment, scheduling and effective cleaning
- Ignoring allergen handling
- Eliminating cleaning procedures
Correct Answer: Dedicated equipment, scheduling and effective cleaning
Q17. Why is process capability (Cp/Cpk) important after transfer?
- It assesses the ability of a process to consistently meet specifications
- It measures employee satisfaction
- It defines packaging aesthetics
- It calculates marketing reach
Correct Answer: It assesses the ability of a process to consistently meet specifications
Q18. What role does design of experiments (DoE) play in scale-up?
- It is used to minimize experimental runs without understanding factors
- It systematically explores CPPs and their effect on CQAs to define robust ranges
- It randomly changes parameters
- It replaces validation entirely
Correct Answer: It systematically explores CPPs and their effect on CQAs to define robust ranges
Q19. Which element is essential in a process transfer report?
- Unverified anecdotal success stories
- Comparative data, deviations, acceptance criteria and conclusions
- Only marketing projections
- Personal opinions without data
Correct Answer: Comparative data, deviations, acceptance criteria and conclusions
Q20. What is a key challenge when transferring analytical methods?
- Ensuring the receiving laboratory has identical instrumentation and trained personnel or suitable equivalents
- Avoiding any documentation
- Removing calibration requirements
- Changing acceptance criteria arbitrarily
Correct Answer: Ensuring the receiving laboratory has identical instrumentation and trained personnel or suitable equivalents
Q21. Which metric helps determine acceptable residue limits in cleaning validation?
- Maximum Acceptable Carryover (MACO) based on toxicity and therapeutic dose
- Employee opinion polls
- Packaging color contrast
- Product launch date
Correct Answer: Maximum Acceptable Carryover (MACO) based on toxicity and therapeutic dose
Q22. What is the purpose of a mock production run during transfer?
- To finalize marketing campaigns
- To simulate production and identify scale-up issues before full production
- To delay regulatory submission
- To reduce staff training
Correct Answer: To simulate production and identify scale-up issues before full production
Q23. Which cleaning acceptance criterion is commonly used for non-toxic residuals?
- 0.1 ppm irrespective of product
- Visual inspection only
- Limit based on TOC (Total Organic Carbon) or specific residue limits derived from MACO
- No criteria required
Correct Answer: Limit based on TOC (Total Organic Carbon) or specific residue limits derived from MACO
Q24. When transferring packaging, what should be verified regarding secondary packaging?
- That it causes maximum product degradation
- Compatibility, print accuracy, tamper evidence and transport robustness
- That it is the cheapest available
- That it eliminates serialization
Correct Answer: Compatibility, print accuracy, tamper evidence and transport robustness
Q25. Which regulatory guideline is most relevant to cleaning validation and GMP expectations?
- ICH Q10 and relevant regional GMP guides
- ISO 9001 only
- Food industry guidelines exclusively
- Local tax regulations
Correct Answer: ICH Q10 and relevant regional GMP guides
Q26. What is the benefit of using worst-case conditions in validation?
- It reduces testing scope by ignoring extremes
- It ensures robustness and control under the most challenging realistic conditions
- It invalidates the process
- It is only useful for marketing
Correct Answer: It ensures robustness and control under the most challenging realistic conditions
Q27. Which document records actual operations during a production batch after transfer?
- Technology Transfer Plan
- Batch Manufacturing Record (BMR) or Batch Production Record (BPR)
- Regulatory submission dossier
- Vendor brochures
Correct Answer: Batch Manufacturing Record (BMR) or Batch Production Record (BPR)
Q28. What is the role of change control during and after transfer?
- To allow undocumented changes at will
- To formally evaluate, approve and document changes that could impact product quality
- To avoid regulatory inspections
- To expedite product release without testing
Correct Answer: To formally evaluate, approve and document changes that could impact product quality
Q29. Which aspect is crucial for personnel training in transfer activities?
- Training is optional for experienced staff only
- Comprehensive training on new processes, SOPs, safety and quality expectations
- Training only on packaging aesthetics
- Training only for marketing staff
Correct Answer: Comprehensive training on new processes, SOPs, safety and quality expectations
Q30. What constitutes successful completion of process transfer?
- Completion of marketing materials
- Demonstrated reproducible production meeting predefined acceptance criteria and regulatory compliance
- Only informal verbal agreement between teams
- Postponement of validation activities
Correct Answer: Demonstrated reproducible production meeting predefined acceptance criteria and regulatory compliance
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