Critical Process Parameters (CPP) MCQs With Answer

Critical Process Parameters (CPP) MCQs With Answer

Introduction: This collection of MCQs on Critical Process Parameters (CPP) is tailored for M.Pharm students studying Pharmaceutical Manufacturing Technology. The questions focus on identifying, evaluating, controlling, and validating CPPs—process variables that directly affect Critical Quality Attributes (CQAs) of drug products. Emphasis is placed on risk assessment, Design of Experiments (DoE), Process Analytical Technology (PAT), control strategies, statistical tools, and practical examples across common unit operations such as granulation, compression, lyophilization and sterilization. Use these questions to deepen conceptual knowledge, prepare for exams, and strengthen the ability to apply Quality by Design (QbD) principles in realistic manufacturing scenarios.

Q1. What best defines a Critical Process Parameter (CPP) in pharmaceutical manufacturing?

• Any operating variable in a process that can be measured
• Process parameters that impact critical quality attributes (CQAs) and must be controlled
• Quality attributes of the final product
• Shelf-life determinants unaffected by production

Correct Answer: Process parameters that impact critical quality attributes (CQAs) and must be controlled

Q2. Which approach is most commonly used to identify CPPs during process development?

• Only transferring vendor SOPs without experiments
• Risk assessment combined with Design of Experiments (DoE) to link parameters to CQAs
• Randomly choosing parameters that are easy to measure
• Relying exclusively on historical batch records

Correct Answer: Risk assessment combined with Design of Experiments (DoE) to link parameters to CQAs

Q3. Which of the following is a typical CPP for tablet compression?

• Tablet color
• Compression force
• Packaging tape width
• Label print quality

Correct Answer: Compression force

Q4. What is the primary role of Process Analytical Technology (PAT) in CPP management?

• To eliminate the need for quality control testing
• To enable real-time monitoring and control of CPPs to ensure product quality
• To reduce operator training requirements
• To standardize packaging formats

Correct Answer: To enable real-time monitoring and control of CPPs to ensure product quality

Q5. According to ICH Q8, what does the term “design space” refer to?

• A single ideal setpoint for all process parameters
• A limited set of final product tests
• A multidimensional combination of input variables and process parameters that assures quality when operated within approved ranges
• An equipment maintenance schedule

Correct Answer: A multidimensional combination of input variables and process parameters that assures quality when operated within approved ranges

Q6. How does Failure Mode and Effects Analysis (FMEA) assist in CPP determination?

• By predicting market demand for the product
• By identifying and prioritizing potential process failures and their impact on CQAs to select CPPs
• By replacing the need for experimental studies
• By defining packaging artwork

Correct Answer: By identifying and prioritizing potential process failures and their impact on CQAs to select CPPs

Q7. Which statistical tool is most appropriate for optimizing CPPs and studying interactions between them?

• Simple linear regression only
• Design of Experiments (DoE)
• Manual trial-and-error without statistical design
• Descriptive statistics like mean and median only

Correct Answer: Design of Experiments (DoE)

Q8. In process validation, what is the purpose of establishing acceptable ranges for CPPs?

• To set arbitrary limits without data
• To ensure the process continues to produce product that meets CQAs during routine manufacturing
• To reduce batch sampling frequency to zero
• To define storage conditions only

Correct Answer: To ensure the process continues to produce product that meets CQAs during routine manufacturing

Q9. Which element is essential in a control strategy for CPPs?

• A checklist for office supplies
• Specification of controls, monitoring, and corrective actions to maintain CPPs within acceptable ranges
• Marketing approval letters
• Only end-product testing without in-process controls

Correct Answer: Specification of controls, monitoring, and corrective actions to maintain CPPs within acceptable ranges

Q10. What is the difference between a setpoint and an upper/lower control limit for a CPP?

• Setpoint is the target operating value; control limits define allowable deviation bounds
• Setpoint is the same as the upper limit
• Control limits are chosen randomly
• Setpoint is only used during cleaning

Correct Answer: Setpoint is the target operating value; control limits define allowable deviation bounds

Q11. For high-risk CPPs, what monitoring frequency is generally preferred?

• Annual review only
• Continuous or real-time monitoring to quickly detect excursions
• Only at final product release
• Monthly manual checks

Correct Answer: Continuous or real-time monitoring to quickly detect excursions

Q12. Which metric is commonly used to assess whether a process can consistently operate within CPP specification limits?

• pH of cleaned water
• Process capability indices such as Cpk
• Color of the product
• Number of operators on shift

Correct Answer: Process capability indices such as Cpk

Q13. When multiple CPPs interact, which multivariate technique helps understand their combined effect on CQAs?

• Univariate t-test only
• Principal Component Analysis (PCA) or Partial Least Squares (PLS)
• Counting the number of batches
• Simple scatterplot without modeling

Correct Answer: Principal Component Analysis (PCA) or Partial Least Squares (PLS)

Q14. Why must CPPs be re-evaluated during scale-up from lab to commercial production?

• Because larger scales always use different APIs
• Because equipment geometry and heat/mass transfer change and can alter CPP behavior
• Scale-up only affects packaging, not CPPs
• Because regulatory documents require re-labeling

Correct Answer: Because equipment geometry and heat/mass transfer change and can alter CPP behavior

Q15. How is a criticality threshold for a CPP typically determined?

• By supplier recommendation only
• By experimental studies showing that deviations beyond the threshold cause CQAs to fail specifications
• By choosing round numbers for convenience
• By the number of operators trained

Correct Answer: By experimental studies showing that deviations beyond the threshold cause CQAs to fail specifications

Q16. What is a best practice for alarm management related to CPP excursions?

• Disable alarms to avoid nuisance alerts
• Use tiered alarms (warning, action) with defined triggers and documented corrective responses
• Only notify QA at year-end
• Record alarms without defining actions

Correct Answer: Use tiered alarms (warning, action) with defined triggers and documented corrective responses

Q17. Which parameter is commonly considered a CPP during lyophilization (freeze-drying)?

• Shelf temperature during primary drying
• Label font size
• Shipping route
• Batch numbering system

Correct Answer: Shelf temperature during primary drying

Q18. In moist-heat sterilization validation, which CPP is critical for achieving sterility assurance?

• Label color
• F0 value representing cumulative lethality based on temperature and time
• Packaging design
• Document revision number

Correct Answer: F0 value representing cumulative lethality based on temperature and time

Q19. What does a robustness study typically involve with respect to CPPs?

• Deliberately varying CPPs within predefined ranges to assess impact on CQAs
• Testing finished product packaging only
• Ignoring CPPs during development
• Only conducting sensory evaluations

Correct Answer: Deliberately varying CPPs within predefined ranges to assess impact on CQAs

Q20. Which type of statistical control chart is commonly used to monitor CPPs for shifts in the process mean?

• Shewhart X-bar chart (and alternatives like CUSUM/EWMA for smaller shifts)
• Pareto chart for operator efficiency
• Histogram of promotional sales
• Venn diagram of quality systems

Correct Answer: Shewhart X-bar chart (and alternatives like CUSUM/EWMA for smaller shifts)

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