Introduction: This collection of MCQs on the audit of capsule production is designed for M.Pharm students preparing for examinations and practical audits in pharmaceutical manufacturing. The questions focus on regulatory expectations, quality attributes, in-process controls, validation requirements, contamination control, documentation and corrective actions specific to hard and soft capsule operations. Each item targets understanding of critical process parameters, sampling plans, environmental considerations, and audit evidence needed to demonstrate compliance with cGMP and international guidance. Working through these questions will deepen practical audit skills and improve readiness for both internal and regulatory inspections in capsule manufacturing environments.
Q1. What is the primary objective of an audit in a capsule production facility?
- To optimize production yield regardless of documentation
- To ensure compliance with current Good Manufacturing Practices (cGMP) and approved processes
- To replace quality control testing
- To evaluate only the packaging department
Correct Answer: To ensure compliance with current Good Manufacturing Practices (cGMP) and approved processes
Q2. Which critical process parameter is most directly monitored to control dose uniformity in hard gelatin capsule filling?
- Capsule shell color
- Fill weight and weight variation
- Environmental temperature only
- Packing line speed
Correct Answer: Fill weight and weight variation
Q3. Which in-process control is essential during capsule filling to detect segregation or blend non-uniformity?
- Routine moisture content of packaging material
- Periodic blend content uniformity sampling and testing
- Operator visual check of capsule color
- Final product dissolution testing only
Correct Answer: Periodic blend content uniformity sampling and testing
Q4. What is the standard initial sample size recommended by USP for content uniformity testing of capsules?
- 5 capsules
- 10 capsules (with possible extension to 30)
- 50 capsules
- 1 capsule per production lot
Correct Answer: 10 capsules (with possible extension to 30)
Q5. Which qualification approach is required to demonstrate proper installation and performance of a capsule filling machine?
- Only operational checks during routine batches
- Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
- Validation by vendor certificate only
- Daily GMP walkaround
Correct Answer: Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
Q6. For a multi-product facility producing capsules with different APIs, which control is most important to prevent cross-contamination?
- Using the same SOP for all products
- Validated cleaning procedures and segregation or dedicated equipment when necessary
- Reducing production speed
- Relying solely on final release testing
Correct Answer: Validated cleaning procedures and segregation or dedicated equipment when necessary
Q7. Why is environmental monitoring performed in non-sterile capsule production areas when handling potent APIs?
- Because all non-sterile areas must meet sterile area limits
- To detect trends and prevent particulate or microbiological contamination that could affect product or operator safety
- To eliminate the need for cleaning validation
- To replace end-product testing
Correct Answer: To detect trends and prevent particulate or microbiological contamination that could affect product or operator safety
Q8. Which critical quality attribute must be audited specifically for soft gelatin capsules?
- Tablet hardness
- Shell seal integrity and absence of leakage
- Coating thickness
- Granule size distribution
Correct Answer: Shell seal integrity and absence of leakage
Q9. During an audit, which document provides the stepwise manufacturing instructions and is essential to verify batch execution for capsules?
- Marketing brochure
- Batch Manufacturing Record (BMR) or Batch Production and Control Record
- Purchase orders
- Stability chamber log only
Correct Answer: Batch Manufacturing Record (BMR) or Batch Production and Control Record
Q10. What audit evidence best demonstrates that corrective actions were effective after a capsule weight variation deviation?
- Unsigned note in the operator logbook
- Trend data showing reduced variation after CAPA implementation and documented verification activities
- Verbal assurance from production staff
- Same-day repeat of a single batch without documentation
Correct Answer: Trend data showing reduced variation after CAPA implementation and documented verification activities
Q11. What is the most common root cause of unacceptable weight variation in powder-filled capsules?
- Excessive coating on capsules
- Poor powder flowability and feed irregularity in the filling system
- Incorrect label formatting
- Worker clothing color
Correct Answer: Poor powder flowability and feed irregularity in the filling system
Q12. Which of the following labeling elements must always be verified by an auditor on finished capsule cartons?
- Graphic design concept
- Batch number and expiry date
- Supplier internal codes
- Operator initials
Correct Answer: Batch number and expiry date
Q13. Which guideline should auditors reference to confirm the stability testing program for capsules?
- ICH Q1A(R2) — Stability Testing of New Drug Substances and Products
- WHO Annex on Sterile Products only
- Local tax regulations
- ISO 9000 general quality manual
Correct Answer: ICH Q1A(R2) — Stability Testing of New Drug Substances and Products
Q14. How are audit findings typically classified according to regulatory inspection practice?
- Low, medium, optional
- Critical, major and minor
- Informal and formal
- Immediate or delayed
Correct Answer: Critical, major and minor
Q15. What is an appropriate acceptance criterion used in cleaning validation to limit carryover between capsule product campaigns?
- Arbitrary visual cleanliness
- Safety-based limits such as a fraction (e.g., 1/1000) of the lowest therapeutic dose or a validated ppm threshold
- Time since last cleaning only
- Manufacturer’s marketing claims
Correct Answer: Safety-based limits such as a fraction (e.g., 1/1000) of the lowest therapeutic dose or a validated ppm threshold
Q16. What quality attribute should be checked during packaging audit of blistered capsule products?
- Tablet friability
- Blister seal integrity and absence of pinholes
- API melting point
- Operator hairnets
Correct Answer: Blister seal integrity and absence of pinholes
Q17. Which documentation practice demonstrates proper control of manufacturing procedures for capsules?
- Unlimited SOP edits without version control
- Controlled SOPs with revision history, approval signatures and associated training records
- Informal emails as the only procedural guidance
- No training records if SOPs are available
Correct Answer: Controlled SOPs with revision history, approval signatures and associated training records
Q18. In an audit, how should an auditor distinguish between disintegration and dissolution tests for capsules?
- Disintegration measures chemical potency; dissolution measures appearance
- Disintegration measures time to break up; dissolution measures rate and extent of drug release into solution
- They are identical tests with different names
- Dissolution is only for injectables
Correct Answer: Disintegration measures time to break up; dissolution measures rate and extent of drug release into solution
Q19. Which practice is recommended when auditing visual inspection and printing of capsules for color and legibility?
- Rely only on operator judgment under variable lighting
- Use calibrated color standards, controlled lighting and documented acceptance criteria
- Approve packaging based on photographs on a phone
- Accept any minor variation without record
Correct Answer: Use calibrated color standards, controlled lighting and documented acceptance criteria
Q20. What is the correct initial step after an Out-of-Specification (OOS) result is observed for capsule potency during QC testing?
- Immediately release the batch based on production history
- Follow the OOS investigation procedure: secure samples, document results, initiate investigation and avoid retesting until investigation plan is documented
- Discard all documentation and repeat testing without investigation
- Notify marketing to change label
Correct Answer: Follow the OOS investigation procedure: secure samples, document results, initiate investigation and avoid retesting until investigation plan is documented
