Introduction: This quiz set on Process Validation for Aerosols is designed for M.Pharm students preparing for advanced coursework and exams in Pharmaceutical Validation. It covers critical aspects of aerosol product validation including stages of validation, critical quality attributes (CQAs) like delivered dose and aerodynamic particle size distribution (APSD), container-closure integrity, in-process controls, and regulatory expectations. The questions emphasize practical understanding of validation protocols, worst-case selection, statistical sampling, test methods (spray pattern, plume geometry), and process capability. Use these MCQs to evaluate your depth of knowledge and to identify areas requiring further study for ensuring robust and compliant aerosol manufacturing processes.
Q1. What is the primary objective of process validation for pressurized metered-dose aerosols (pMDIs)?
- To perform routine stability testing after market launch
- To ensure the process performs consistently to produce product meeting predetermined specifications
- To eliminate the need for in-process controls
- To replace finished-product testing entirely
Correct Answer: To ensure the process performs consistently to produce product meeting predetermined specifications
Q2. Which stage of process validation involves continued monitoring of process performance and product quality during routine production?
- Stage 1 — Process Design
- Stage 2 — Process Qualification
- Stage 3 — Continued Process Verification
- Pilot-Scale Feasibility
Correct Answer: Stage 3 — Continued Process Verification
Q3. For aerosol products, which test is most appropriate to assess the respirable fraction of emitted dose?
- Leak test
- Delivered dose uniformity (DDU)
- Aerodynamic particle size distribution (APSD) using cascade impactor
- Plume geometry measurement
Correct Answer: Aerodynamic particle size distribution (APSD) using cascade impactor
Q4. Which parameter is typically considered a critical process parameter (CPP) for pMDI filling?
- Color of the lacquer coating
- Filling valve tension and fill volume
- Label artwork design
- Room lighting intensity
Correct Answer: Filling valve tension and fill volume
Q5. When selecting worst-case batches for validation of an aerosol, which approach is most appropriate?
- Choose the batches with the median particle size and dose
- Select extremes for drug concentration, propellant ratio, and fill weight that challenge the process
- Pick only batches that passed all QC tests
- Randomly select any three batches regardless of variance
Correct Answer: Select extremes for drug concentration, propellant ratio, and fill weight that challenge the process
Q6. Delivered dose uniformity (DDU) requirements for metered-dose inhalers are primarily intended to ensure:
- That the packaging is visually appealing
- Consistent amount of drug delivered per actuation over life of canister
- That the propellant composition remains constant
- Microbial sterility of the drug formulation
Correct Answer: Consistent amount of drug delivered per actuation over life of canister
Q7. Which analytical method is considered most suitable as a stability-indicating assay for an aerosol drug substance in validation studies?
- Non-specific UV absorbance without separation
- Validated HPLC method capable of separating degradation products
- Gravimetric measurement only
- Simple pH measurement
Correct Answer: Validated HPLC method capable of separating degradation products
Q8. In-process control for spray pattern and plume geometry are used during validation to:
- Assess container labeling alignment
- Characterize aerosol performance and spray shape that affect deposition
- Measure microbial load in the propellant
- Determine expiration dating
Correct Answer: Characterize aerosol performance and spray shape that affect deposition
Q9. For a suspension pMDI, which parameter is especially critical to monitor during validation to ensure dose uniformity?
- Stirrer color
- Suspension homogeneity and valve/product actuation interval
- Packaging font size
- Ambient noise level in the filling room
Correct Answer: Suspension homogeneity and valve/product actuation interval
Q10. Container-closure integrity (CCI) testing for aerosols primarily verifies:
- The color consistency of the canister
- Absence of leaks that could change pressure or allow contamination
- Correct printing on the label
- That the valve actuates smoothly
Correct Answer: Absence of leaks that could change pressure or allow contamination
Q11. Which statistical tool is most commonly applied to demonstrate process capability during aerosol validation?
- Kaplan-Meier survival analysis
- Process Capability Indices (Cp, Cpk)
- Student’s t-test for two independent samples only
- ANOVA for color matching
Correct Answer: Process Capability Indices (Cp, Cpk)
Q12. For pressurized aerosols, what is the main regulatory expectation regarding microbial limits in non-sterile formulations?
- No microbial testing is required for aerosols
- Meet specified microbiological limits and include preservative effectiveness if applicable
- All aerosol products must be sterile
- Only test for endotoxins
Correct Answer: Meet specified microbiological limits and include preservative effectiveness if applicable
Q13. Which validation activity directly addresses assurance that residue from cleaning does not contaminate subsequent aerosol batches?
- Container-closure integrity testing
- Cleaning validation with residue quantification and rinsate limits
- Plume geometry measurement
- Label verification
Correct Answer: Cleaning validation with residue quantification and rinsate limits
Q14. In aerosol process validation, a Design of Experiments (DoE) study is most useful for:
- Replacing all QC tests with statistical models
- Identifying and quantifying the influence of multiple factors on CQAs
- Selecting label fonts and colors
- Determining marketing strategies
Correct Answer: Identifying and quantifying the influence of multiple factors on CQAs
Q15. Which acceptance criterion is commonly set for aerodynamic particle size distribution (MMAD) in inhalation products?
- MMAD must be less than 0.1 µm
- MMAD should lie within a product-specific target range (e.g., 1–5 µm) relevant to site of deposition
- MMAD is irrelevant for aerosols
- MMAD must be above 10 µm for systemic delivery
Correct Answer: MMAD should lie within a product-specific target range (e.g., 1–5 µm) relevant to site of deposition
Q16. Which environmental control is crucial during filling and assembly of pMDIs to maintain product quality?
- Control of room color scheme
- Control of temperature, relative humidity, and particulate contamination
- Control of staff shoe size
- Control of music volume in production area
Correct Answer: Control of temperature, relative humidity, and particulate contamination
Q17. During process qualification, how many consecutive batches are typically recommended to demonstrate reproducible performance for a new aerosol product? (Regulatory guidance varies — choose the most commonly cited number.)
- One batch
- Two batches
- Three consecutive full-scale batches
- Ten batches
Correct Answer: Three consecutive full-scale batches
Q18. Which test specifically evaluates the function and performance of the metering valve in an aerosol canister?
- Valve torque test and leak pressure test along with delivered dose per actuation
- pH of formulation
- Antimicrobial preservative assay
- Visual inspection of label alignment
Correct Answer: Valve torque test and leak pressure test along with delivered dose per actuation
Q19. When establishing sampling plans for validation of aerosol products, which principle should be followed?
- Use the smallest sample possible to save cost even if not statistically justified
- Base sample size on risk, variability, and statistical confidence to support conclusions
- Sample only failed batches
- Use arbitrary numbers without documentation
Correct Answer: Base sample size on risk, variability, and statistical confidence to support conclusions
Q20. What is the role of accelerated and stress stability studies in aerosol validation?
- They are only for cosmetics and not relevant to aerosols
- To predict potential degradation pathways, shelf-life risks, and to support specification limits
- To replace real-time stability entirely
- To test the mechanical strength of shipping cartons
Correct Answer: To predict potential degradation pathways, shelf-life risks, and to support specification limits
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