Introduction: Qualification of capsule filling machines is a critical component of pharmaceutical validation that ensures equipment consistently produces capsules meeting predefined quality attributes. For M.Pharm students, understanding IQ, OQ and PQ phases, critical process parameters, acceptance criteria, and common failure modes is essential for regulatory compliance and product safety. This blog-style quiz focuses on core concepts such as machine types (dosator, tamping, auger), fill-weight control, in-process checks, environmental and utility considerations, cleaning and change-over, and statistical sampling for validation. The questions are designed to reinforce theory and practical decision-making needed during equipment qualification and validation protocols.
Q1. Which phase of equipment qualification documents that the capsule filling machine is installed according to manufacturer and facility requirements?
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Installation Qualification (IQ)
- Process Validation (PV)
Correct Answer: Installation Qualification (IQ)
Q2. During OQ for a capsule filling machine, which parameter is typically challenged to verify consistent performance?
- Room air change rate
- Maximum fill-weight accuracy at different speeds
- Packaging label accuracy
- Raw material microbial limit
Correct Answer: Maximum fill-weight accuracy at different speeds
Q3. What is the primary focus of Performance Qualification (PQ) for a capsule filling machine?
- Verifying electrical wiring details
- Confirming the machine performs reliably under simulated or actual production conditions
- Documenting the supplier’s quality systems
- Testing individual components for material composition
Correct Answer: Confirming the machine performs reliably under simulated or actual production conditions
Q4. Which machine type uses a dosator to pick up powdered fill and release it into capsule bodies?
- Auger filler
- Dosator filler
- Rotary tablet press
- Liquid fill-seal machine
Correct Answer: Dosator filler
Q5. In qualification studies, what is considered a critical process parameter (CPP) for capsule fill-weight control?
- Operator shift schedule
- Ambient wall paint color
- Dosator depth, tamping force or auger speed
- Invoice number of raw material
Correct Answer: Dosator depth, tamping force or auger speed
Q6. Which acceptance criterion is commonly used for fill-weight variation during PQ of capsule machines?
- All capsules within ±50% of label claim
- Mean fill-weight within specification and a defined percentage (e.g., 95%) within ±5% of target
- No capsule should be visibly damaged
- All capsules should pass dissolution at 5 minutes
Correct Answer: Mean fill-weight within specification and a defined percentage (e.g., 95%) within ±5% of target
Q7. Which test during qualification verifies the capsule filling machine correctly orients and closes capsules without loss of content?
- Environmental monitoring
- Capsule closure and orientation check
- Microbial challenge test
- Visual inspection of packaging
Correct Answer: Capsule closure and orientation check
Q8. Why is worst-case selection important when qualifying capsule filling machines?
- To minimize documentation
- To challenge the process with the most difficult-to-fill formulations and highest operating speeds
- To ensure the cheapest raw material is used
- To avoid performing OQ
Correct Answer: To challenge the process with the most difficult-to-fill formulations and highest operating speeds
Q9. Which validation activity ensures cleaning procedures for a capsule filling machine are adequate to prevent cross-contamination?
- Process mapping
- Cleaning Validation
- Environmental qualification
- Packaging compatibility study
Correct Answer: Cleaning Validation
Q10. During IQ/OQ/PQ documentation, what is the purpose of calibration of measurement devices attached to the machine (e.g., weight scales)?
- To reduce operator workload
- To ensure accurate and traceable measurements used for acceptance criteria
- To improve machine aesthetics
- To increase production speed
Correct Answer: To ensure accurate and traceable measurements used for acceptance criteria
Q11. Which in-process control is routinely monitored to detect segregation or variation in fill material during a capsule run?
- Ambient humidity only before start-up
- Continuous weight checks and periodic visual inspection of tamping/dosing
- Final packaging seal integrity
- Operator hand hygiene
Correct Answer: Continuous weight checks and periodic visual inspection of tamping/dosing
Q12. What is a common cause of capsule fill-weight drift that should be investigated in OQ/PQ?
- Incorrect invoice coding
- Wear of dosing discs, change in feed frame agitation or powder compaction changes
- Ambient light intensity
- Incorrect label artwork
Correct Answer: Wear of dosing discs, change in feed frame agitation or powder compaction changes
Q13. For statistical sampling during PQ of capsule fill weight, which approach is commonly used?
- Test only one capsule per batch
- Use predetermined sample sizes (e.g., 10 per timepoint) and apply statistical acceptance limits
- Test every capsule produced
- Use only visual inspection without weight checks
Correct Answer: Use predetermined sample sizes (e.g., 10 per timepoint) and apply statistical acceptance limits
Q14. Which utility qualification is relevant for capsule filling machines that use vacuum systems or compressed air?
- Vacuum and compressed air supply qualification
- Internet connectivity test
- Pharmaceutical waste disposal validation
- Lighting intensity measurement
Correct Answer: Vacuum and compressed air supply qualification
Q15. Why is change-over time and procedure evaluated during qualification of capsule filling machines?
- To maximize machine downtime for maintenance only
- To ensure rapid, reproducible cleaning and setup that minimizes cross-contamination and downtime
- To test operator friendliness of the control panel
- To alter the machine serial number
Correct Answer: To ensure rapid, reproducible cleaning and setup that minimizes cross-contamination and downtime
Q16. What is the significance of conducting a challenge test for capsule leakage during PQ?
- To determine packaging aesthetics
- To verify capsule closure integrity under worst-case mechanical or environmental stress
- To check label adhesion
- To test operator dexterity
Correct Answer: To verify capsule closure integrity under worst-case mechanical or environmental stress
Q17. Which operational factor is important to record during PQ runs because it can influence powder flow and fill accuracy?
- Operator’s favorite color
- Environmental temperature and relative humidity
- Supplier’s country of origin
- Time of day only
Correct Answer: Environmental temperature and relative humidity
Q18. In validating an auger filler capsule machine, which component condition must be checked to ensure consistent dosing?
- Label printer alignment
- Auger pitch, diameter and wear of the auger flights
- Type of flooring under the machine
- Operator shoe size
Correct Answer: Auger pitch, diameter and wear of the auger flights
Q19. Which document typically defines the criteria, tests and acceptance limits for IQ/OQ/PQ of a capsule filling machine?
- Purchase order only
- Validation Master Plan (VMP) and specific Validation Protocols
- Marketing brochure
- Operator’s personal notes
Correct Answer: Validation Master Plan (VMP) and specific Validation Protocols
Q20. When should requalification of a capsule filling machine be performed?
- Only when the facility moves to a new city
- After major maintenance, equipment modification, or if performance deviations are observed
- Never after initial qualification
- Only when a new operator is hired
Correct Answer: After major maintenance, equipment modification, or if performance deviations are observed
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