Optimization and production transfer MCQs With Answer

Introduction: Optimization and production transfer MCQs With Answer is designed for M. Pharm students preparing for advanced exams in product development and technology transfer. This set of focused multiple-choice questions covers critical concepts such as design of experiments (DoE), quality by design (QbD), critical quality attributes (CQAs), critical process parameters (CPPs), process analytical technology (PAT), scale-up principles, technology transfer documentation, risk assessment tools, and regulatory expectations. The questions emphasize practical decision-making during optimization and transfer from development to commercial manufacture, including analytical and aseptic transfers. Each question is accompanied by clear options and the correct answer to reinforce learning and support mastery of topics needed for both academics and industry practice.

Q1. What does the term “design space” refer to in Pharmaceutical Quality by Design (QbD)?

• The range of material suppliers approved for a product
• The multidimensional combination of input variables and process parameters that assure product quality
• The physical layout drawing of the manufacturing plant
• The set of finished product specifications established by the regulatory authority

Correct Answer: The multidimensional combination of input variables and process parameters that assure product quality

Q2. What is the primary objective of a technology transfer from R&D to a manufacturing site?

• To reduce production cost by 50%
• To ensure successful, reproducible manufacturing at the recipient site while maintaining product quality and regulatory compliance
• To replace all equipment with newer models
• To develop new analytical methods irrespective of product requirements

Correct Answer: To ensure successful, reproducible manufacturing at the recipient site while maintaining product quality and regulatory compliance

Q3. Which of the following best defines a Critical Quality Attribute (CQA)?

• An administrative document required for regulatory submission
• A physical, chemical, biological, or microbiological property that must be within an appropriate limit to ensure product quality
• An equipment maintenance schedule
• A marketing characteristic of the finished product

Correct Answer: A physical, chemical, biological, or microbiological property that must be within an appropriate limit to ensure product quality

Q4. Which scale-up criterion is most commonly used to maintain similar mixing performance in stirred tank reactors?

• Maintaining constant impeller diameter
• Maintaining constant power per unit volume (P/V)
• Maintaining constant vessel height
• Maintaining identical motor brand

Correct Answer: Maintaining constant power per unit volume (P/V)

Q5. During which stage of process validation is the commercial-scale process performance documented and qualified?

• Stage 1: Process Design
• Stage 2: Process Qualification
• Stage 3: Continued Process Verification
• Stage 4: Market Surveillance

Correct Answer: Stage 2: Process Qualification

Q6. Which item is least likely to be part of a complete technology transfer package?

• Process flow diagrams, batch records, and control strategy
• Analytical methods and validation data
• Regulatory submission and comparability data
• Marketing strategy and promotional materials

Correct Answer: Marketing strategy and promotional materials

Q7. Which risk assessment tool is commonly used to prioritize risks during process optimization and technology transfer?

• SWOT analysis (Strengths, Weaknesses, Opportunities, Threats)
• Failure Mode and Effects Analysis (FMEA)
• Cost-Benefit Analysis
• Delphi method

Correct Answer: Failure Mode and Effects Analysis (FMEA)

Q8. What is the main purpose of Process Analytical Technology (PAT) in process optimization?

• To replace GMP requirements
• To perform end-product release testing only
• To enable real-time monitoring and control of critical process parameters and quality attributes
• To increase the number of offline quality tests

Correct Answer: To enable real-time monitoring and control of critical process parameters and quality attributes

Q9. How does Cpk differ from Cp in process capability analysis?

• Cpk measures only spread, Cp measures mean shift
• Cp accounts for process centering, Cpk ignores centering
• Cpk accounts for both process variation and how close the process mean is to the specification limits, while Cp only measures potential capability based on variation
• They are identical metrics with different names

Correct Answer: Cpk accounts for both process variation and how close the process mean is to the specification limits, while Cp only measures potential capability based on variation

Q10. What is the primary focus during analytical method transfer between labs?

• Changing the method to suit the receiving lab’s preference
• Demonstrating equivalence of method performance characteristics such as accuracy, precision, specificity, and robustness
• Eliminating system suitability criteria
• Only comparing chromatograms visually

Correct Answer: Demonstrating equivalence of method performance characteristics such as accuracy, precision, specificity, and robustness

Q11. Which activity is most critical when transferring an aseptic manufacturing process to a new site?

• Rewriting the product monograph
• Conducting media fill (aseptic process simulation) to demonstrate sterility assurance and operator performance
• Changing the sterilization method without justification
• Reducing environmental monitoring frequency

Correct Answer: Conducting media fill (aseptic process simulation) to demonstrate sterility assurance and operator performance

Q12. A frequent cause of failed transfers is incomplete or unclear batch records. Which corrective action directly addresses this problem?

• Hiring more operators
• Improving and standardizing batch records with clear stepwise work instructions and acceptance criteria
• Outsourcing production to a contract manufacturer without documentation
• Reducing training requirements

Correct Answer: Improving and standardizing batch records with clear stepwise work instructions and acceptance criteria

Q13. Which critical process parameter most directly influences tablet dissolution rate during optimization?

• Tablet coating color
• Particle size distribution of the granules or API
• Ambient music in the production area
• Batch numbering scheme

Correct Answer: Particle size distribution of the granules or API

Q14. Which statistical approach is most appropriate for optimization when studying curvature and interaction effects among variables?

• One-factor-at-a-time screening
• Response Surface Methodology (RSM)
• Simple linear regression only
• Descriptive statistics

Correct Answer: Response Surface Methodology (RSM)

Q15. For process qualification of a new commercial line, regulatory guidance commonly expects how many consecutive successful production batches for small molecule drugs?

• One validation batch
• Three consecutive successful commercial-scale batches
• Ten pilot-scale batches
• No batches are required if lab data exists

Correct Answer: Three consecutive successful commercial-scale batches

Q16. When transferring manufacturing to a different country, what regulatory action is typically required?

• No communication with regulators is ever required
• Regulatory notification or submission with comparability and validation data, as required by the specific health authority
• Only a local business license is sufficient
• Changing product formulation to avoid submissions

Correct Answer: Regulatory notification or submission with comparability and validation data, as required by the specific health authority

Q17. What is the principal purpose of a control strategy in the context of product development and transfer?

• To document the building layout
• To define the combination of controls, parameters, and monitoring intended to ensure product quality and process consistency
• To increase the number of quality tests arbitrarily
• To postpone process characterization until after launch

Correct Answer: To define the combination of controls, parameters, and monitoring intended to ensure product quality and process consistency

Q18. During analytical transfer, which acceptance criteria are commonly predefined to establish successful transfer?

• No criteria; subjective review only
• Predefined statistical limits for accuracy (bias) and precision (RSD) and agreement with reference laboratory results
• Only visual similarity of chromatograms
• Changing specifications to match receiving lab results

Correct Answer: Predefined statistical limits for accuracy (bias) and precision (RSD) and agreement with reference laboratory results

Q19. Which physical parameter becomes increasingly important when scaling up exothermic crystallization processes?

• Surface area to volume ratio affecting heat removal
• Color of the reactor paint
• Name of the process engineer
• Batch record font size

Correct Answer: Surface area to volume ratio affecting heat removal

Q20. What should a comprehensive technology transfer report include to ensure a successful handover?

• Only the process flow diagram
• Complete dossier including process descriptions, master batch records, validation protocols and reports, analytical methods, equipment qualifications, training records, and risk assessments
• Only marketing approval letters
• Only equipment purchase invoices

Correct Answer: Complete dossier including process descriptions, master batch records, validation protocols and reports, analytical methods, equipment qualifications, training records, and risk assessments

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