Process validation for capsules MCQs With Answer

Process validation for capsules MCQs With Answer

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Introduction: Process validation for capsules MCQs With Answer is designed for M.Pharm students to strengthen understanding of validation principles applied specifically to capsule manufacturing. This set covers the regulatory framework, stages of validation (design, qualification, continued verification), critical quality attributes (CQAs), critical process parameters (CPPs), and practical aspects like IQ/OQ/PQ, cleaning validation, sampling strategies, bracketing/matrixing, PAT tools, scale-up and statistical evaluation. Emphasis is placed on identifying worst‑case scenarios, establishing acceptance criteria, and applying analytical and statistical tools to demonstrate consistent capsule quality. These MCQs deepen conceptual knowledge and prepare students for application in real-world pharmaceutical validation projects.

Q1. What is the FDA 2011 definition of process validation?

  • Documented evidence that a product formulation is safe for patient use
  • Demonstration through scientific evidence that a process will consistently produce a product meeting its predetermined specifications and quality attributes
  • A one‑time performance test of production equipment
  • Routine monitoring of the finished product only

Correct Answer: Demonstration through scientific evidence that a process will consistently produce a product meeting its predetermined specifications and quality attributes

Q2. Which three lifecycle stages constitute process validation according to current regulatory guidance?

  • Design verification, stability testing, market surveillance
  • Process design, process qualification, continued process verification
  • Raw material testing, product release, pharmacovigilance
  • Equipment qualification, method validation, batch record review

Correct Answer: Process design, process qualification, continued process verification

Q3. What is the correct purpose/order of IQ, OQ and PQ during equipment qualification?

  • IQ verifies performance, OQ checks installation, PQ documents maintenance
  • IQ documents installation to specifications, OQ verifies operation under defined limits, PQ demonstrates performance under simulated or actual production conditions
  • OQ is performed before IQ, PQ is optional
  • PQ verifies installation, IQ tests process, OQ is product release

Correct Answer: IQ documents installation to specifications, OQ verifies operation under defined limits, PQ demonstrates performance under simulated or actual production conditions

Q4. How are critical process parameters (CPPs) and critical quality attributes (CQAs) related?

  • CPPs are product characteristics and CQAs are equipment settings
  • CPPs are process parameters that when varied have a significant impact on CQAs, which are the measurable properties that must be within limits
  • CQAs are always temperature and humidity only
  • CPPs only relate to cleaning operations and not to product quality

Correct Answer: CPPs are process parameters that when varied have a significant impact on CQAs, which are the measurable properties that must be within limits

Q5. What is the minimum number of consecutive successful commercial-scale batches typically expected for performance qualification (PQ)?

  • One
  • Two
  • Three
  • Five

Correct Answer: Three

Q6. Which statement correctly describes bracketing and matrixing in validation strategy?

  • Bracketing tests all combinations of strengths and container sizes; matrixing tests only the largest size
  • Bracketing means testing a full matrix of conditions; matrixing means testing only extremes
  • Bracketing tests extremes (e.g., highest and lowest strengths/containers) while matrixing reduces the number of tests by sampling combinations across a design space
  • Both terms refer to cleaning validation approaches only

Correct Answer: Bracketing tests extremes (e.g., highest and lowest strengths/containers) while matrixing reduces the number of tests by sampling combinations across a design space

Q7. How should “worst‑case” conditions be selected for capsule process validation?

  • Choose conditions that are easiest to clean and test
  • Select parameters and product variants that present the highest risk to product quality based on formulation, potency, solubility and equipment interaction
  • Always use the nominal (target) operating point only
  • Pick random conditions without risk assessment

Correct Answer: Select parameters and product variants that present the highest risk to product quality based on formulation, potency, solubility and equipment interaction

Q8. What is the appropriate method to demonstrate blend uniformity for capsule filling?

  • Single assay of one blend sample at process end
  • Assay of multiple spatially distributed samples of the blend and finished capsules to calculate variability (e.g., RSD) and demonstrate uniformity
  • Visual inspection of color uniformity only
  • Measuring capsule fill volume with a ruler

Correct Answer: Assay of multiple spatially distributed samples of the blend and finished capsules to calculate variability (e.g., RSD) and demonstrate uniformity

Q9. For continuous capsule manufacturing, what is a key validation requirement not typically present in batch manufacturing?

  • Demonstrating steady‑state operation and control over process mean and variability for an extended production period
  • Only validating raw materials is required
  • Continuous processes do not require any validation
  • Validation of stability only after 5 years

Correct Answer: Demonstrating steady‑state operation and control over process mean and variability for an extended production period

Q10. What target value for process capability index (Cpk) is commonly used as a minimum indicator of acceptable process capability in pharmaceutical manufacturing?

  • Cpk = 0.5
  • Cpk ≥ 1.33
  • Cpk = 0
  • Cpk ≤ 1.0

Correct Answer: Cpk ≥ 1.33

Q11. When selecting a worst‑case product for cleaning validation in a shared capsule production line, which factor is most important?

  • Colour of the product only
  • Potency, toxicity, solubility and cleaning difficulty of the product residues
  • Packaging label design
  • Employee preference

Correct Answer: Potency, toxicity, solubility and cleaning difficulty of the product residues

Q12. Which sampling strategy is most appropriate for in‑process sampling of finished capsules to assess batch homogeneity?

  • Grab sampling from one convenient location only
  • Systematic random sampling (stratified across the fill sequence or container positions) to capture spatial/temporal variability
  • Sampling only the first ten capsules produced
  • Only sampling after product release

Correct Answer: Systematic random sampling (stratified across the fill sequence or container positions) to capture spatial/temporal variability

Q13. Which PAT (process analytical technology) tool is frequently used for real‑time monitoring of blend uniformity and content in capsule manufacturing?

  • Ultraviolet light inspection without instrumentation
  • Near‑infrared (NIR) spectroscopy for non‑destructive, at‑line or in‑line monitoring of blend uniformity and moisture
  • Thermometer only
  • Manual weight measurement of a single unit

Correct Answer: Near‑infrared (NIR) spectroscopy for non‑destructive, at‑line or in‑line monitoring of blend uniformity and moisture

Q14. Which change would typically trigger revalidation of a capsule manufacturing process?

  • Changing the break room furniture
  • Significant changes to process parameters, equipment, site of manufacture, supplier of critical excipient, or persistent out‑of‑specification trends
  • Changing employee uniforms color
  • Replacing single non‑critical light bulb in corridor

Correct Answer: Significant changes to process parameters, equipment, site of manufacture, supplier of critical excipient, or persistent out‑of‑specification trends

Q15. In dissolution profile comparison for validation of a capsule formulation, which similarity factor indicates the two profiles are similar?

  • f1 = 100
  • f2 ≥ 50
  • f2 ≤ 20
  • f1 ≥ 80

Correct Answer: f2 ≥ 50

Q16. Which test is commonly used to detect leaks or poor sealing in soft gelatin capsule shells during validation?

  • Dye penetration (dye ingress) or vacuum/leak detection to identify shell leaks
  • Assay by UV only
  • Visually checking the color with naked eye is sufficient
  • Measuring capsule length with calipers only

Correct Answer: Dye penetration (dye ingress) or vacuum/leak detection to identify shell leaks

Q17. What must be demonstrated during scale‑up validation from pilot to commercial capsule production?

  • Only that the capsule color matches between scales
  • Comparable critical quality attributes (content uniformity, dissolution, weight variation) and identification/control of scale‑dependent critical process parameters
  • That pilot equipment is physically larger
  • That production cost increases predictably

Correct Answer: Comparable critical quality attributes (content uniformity, dissolution, weight variation) and identification/control of scale‑dependent critical process parameters

Q18. Which elements are essential components of a Validation Master Plan (VMP) for capsule manufacturing?

  • Only the list of employees and cafeteria menu
  • Scope, responsibilities, validation strategy, documentation hierarchy, schedule, and acceptance criteria for processes, equipment and utilities
  • Only the list of approved suppliers
  • Only the batch production records

Correct Answer: Scope, responsibilities, validation strategy, documentation hierarchy, schedule, and acceptance criteria for processes, equipment and utilities

Q19. Which statistical tools are commonly applied during process validation to analyze variability and demonstrate control?

  • ANOVA, control charts (SPC), capability analysis (Cp/Cpk), regression and design of experiments (DoE)
  • Only simple averages with no variability analysis
  • Horoscope charts and opinion polls
  • Only visual inspection with no numeric analysis

Correct Answer: ANOVA, control charts (SPC), capability analysis (Cp/Cpk), regression and design of experiments (DoE)

Q20. What is the purpose of a stability commitment following process validation and regulatory submission for a new capsule product?

  • To postpone stability testing indefinitely
  • To generate ongoing stability data post‑approval (concurrent or post‑approval commitment) until sufficient shelf‑life data are available to support labelled expiry
  • To perform stability testing only for the validation batches and then stop
  • To avoid any stability testing if in‑process controls are robust

Correct Answer: To generate ongoing stability data post‑approval (concurrent or post‑approval commitment) until sufficient shelf‑life data are available to support labelled expiry

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