Introduction
The following quiz focuses on auditing granulation, tableting and coating processes—core manufacturing steps in solid oral dosage production. It is designed for M.Pharm students preparing for regulatory inspections, internal audits, or quality assurance responsibilities. Questions emphasize critical control points, in-process checks, documentation, process validation, equipment and cleaning qualifications, and common failure modes observed during audits. Practical aspects such as sampling, data integrity, OOS/OOT handling, and corrective actions are included to strengthen audit readiness. Use these MCQs to test and deepen your understanding of how regulatory expectations translate into effective audit practices for granulation, tablet compression and coating operations.
Q1. What is the primary objective of an audit focused on granulation, tableting and coating operations?
- To maximize production throughput regardless of quality
- To ensure compliance with established procedures and GMP
- To replace validation with routine checks
- To eliminate the need for in-process controls
Correct Answer: To ensure compliance with established procedures and GMP
Q2. Which document is most critical for an auditor to review when assessing a tablet compression batch?
- Marketing authorization dossier
- Certificate of analysis for raw materials only
- Complete batch manufacturing record (BMR/BPR)
- Training matrix of personnel
Correct Answer: Complete batch manufacturing record (BMR/BPR)
Q3. During granulation audits, which in-process parameter is most important to monitor to ensure consistent tableting performance?
- Color of the granulator paint
- Granule moisture content
- Operator lunch breaks
- Supplier invoice dates
Correct Answer: Granule moisture content
Q4. What is the best approach when an auditor encounters missing entries in an in-process control log?
- Ignore them if the final product passed testing
- Require an investigation and review of supporting evidence
- Delete the record to avoid non-compliance
- Accept a verbal explanation without documentation
Correct Answer: Require an investigation and review of supporting evidence
Q5. Which parameter is a critical quality attribute (CQA) for tablets that an auditor should verify during a coating audit?
- Tablet color only
- Tablet hardness and dissolution profile
- Supplier lead time
- Packaging artwork alignment
Correct Answer: Tablet hardness and dissolution profile
Q6. What is an auditor looking for in equipment qualification records for a coating pan?
- Only the manufacturer name
- IQ/OQ/PQ documentation showing performance to specification
- Sales brochures and promotional material
- Operator opinions about the equipment
Correct Answer: IQ/OQ/PQ documentation showing performance to specification
Q7. Which PAT (process analytical technology) tool is commonly used to monitor granulation end-point in real time?
- Near Infrared (NIR) spectroscopy
- Gas chromatography
- Atomic absorption spectroscopy
- Polarimetry
Correct Answer: Near Infrared (NIR) spectroscopy
Q8. For tablet coating, what is the primary reason for controlling inlet air temperature and spray rate?
- To reduce batch documentation
- To ensure uniform film formation and prevent defects like orange peel or peeling
- To increase tablet weight by absorbing solvent
- To avoid cleaning the coating pan
Correct Answer: To ensure uniform film formation and prevent defects like orange peel or peeling
Q9. Which cleaning validation evidence should an auditor request for granulation and tableting equipment?
- Visual inspection photographs only
- Validated methods with residue limits, sampling results and rinse/swab data
- Employee testimonials
- Purchase orders for cleaning agents
Correct Answer: Validated methods with residue limits, sampling results and rinse/swab data
Q10. When an out-of-specification (OOS) dissolution result is observed post-coating, what is the auditor’s expectation for the manufacturer?
- Ignore the result if other tests are okay
- Initiate a documented investigation, root cause analysis and CAPA
- Blame the laboratory analyst publicly
- Re-test without documenting initial result
Correct Answer: Initiate a documented investigation, root cause analysis and CAPA
Q11. Which risk-based element should auditors assess during a granulation process review?
- Number of office plants
- Identification and control of critical process parameters (CPPs)
- Length of company holiday list
- Color of operators’ uniforms
Correct Answer: Identification and control of critical process parameters (CPPs)
Q12. What sampling plan is appropriate for in-process weight variation checks during tablet compression?
- Random sampling with justification and appropriate sample size based on statistical plan
- Sample the first tablet only
- Weigh tablets only at the end of the campaign
- Use supplier certificate values instead of measuring
Correct Answer: Random sampling with justification and appropriate sample size based on statistical plan
Q13. Which coating defect indicates poor adhesion or inappropriate formulation of the coating solution?
- Glossy finish
- Pilling and flaking
- Uniform color
- Even thickness
Correct Answer: Pilling and flaking
Q14. During an audit, why is data integrity review critical for process control and release decisions?
- Data integrity is irrelevant to product quality
- Ensures records are complete, attributable, legible, contemporaneous and accurate (ALCOA+) for reliable decisions
- To reduce paperwork only
- To allow post-hoc changes to pass inspections
Correct Answer: Ensures records are complete, attributable, legible, contemporaneous and accurate (ALCOA+) for reliable decisions
Q15. What is the auditor’s expectation regarding change control for formulation or equipment changes affecting tablet quality?
- Minor changes never require documentation
- All significant changes must follow change control with risk assessment, validation and documentation
- Change control applies only to packaging
- Changes can be implemented verbally
Correct Answer: All significant changes must follow change control with risk assessment, validation and documentation
Q16. Which inspection focus is most relevant when auditing the lubrication and compression settings of a tablet press?
- Label font size
- Monitoring of compression force, punch/die condition and lubrication to prevent capping and lamination
- Number of visitors in the facility
- Sales department KPIs
Correct Answer: Monitoring of compression force, punch/die condition and lubrication to prevent capping and lamination
Q17. What should an auditor verify regarding microbiological control in aqueous coating operations?
- No microbial risk if film coat is colored
- Controls for microbial contamination of coating solutions, regular testing and preservative effectiveness if applicable
- Only final product sterility testing is required
- Coating rooms can be cleaned weekly without records
Correct Answer: Controls for microbial contamination of coating solutions, regular testing and preservative effectiveness if applicable
Q18. Which evidence demonstrates effective process validation for granulation and tableting?
- One successful batch without documentation
- Prospective or concurrent validation with defined acceptance criteria, multiple batches and supporting data
- Vendor certificates only
- Operator comments that process “looks fine”
Correct Answer: Prospective or concurrent validation with defined acceptance criteria, multiple batches and supporting data
Q19. What is the auditor likely to check in relation to blend uniformity prior to compression?
- Whether the blender paint color is uniform
- Validated sampling and assay results demonstrating content uniformity across samples
- Only the blender model number
- Shipping documents for the blender
Correct Answer: Validated sampling and assay results demonstrating content uniformity across samples
Q20. When reviewing corrective and preventive actions (CAPA) after coating defects, what demonstrates an effective CAPA?
- CAPA logged but no follow-up or verification
- Root cause analysis, implemented corrective actions, effectiveness checks and updated procedures to prevent recurrence
- Immediate hiring of a new operator without investigation
- Deleting the nonconformance record
Correct Answer: Root cause analysis, implemented corrective actions, effectiveness checks and updated procedures to prevent recurrence
