What this round covers
- Granulation and compression defects
- Line clearance and reconciliation
- In-process controls
- BMR and batch documentation
- Equipment changeover
10 Production interview questions with answers
- Q1DocumentationBeginner
Which document gives batch-specific manufacturing instructions?
Model answer: The BMR is the batch-specific issued copy of the master formula with actual entries.
- Controlled issue
- Contemporaneous entries
- Reconciliation
- Q2GMPBeginner
Line clearance before starting a new batch is done to:
Model answer: Line clearance verifies removal of previous product, documents and materials before starting.
- Two-person check
- Checklist record
- Status labelling
- Q3GranulationIntermediate
Which granulation method suits moisture-sensitive drugs?
Model answer: Roller compaction avoids water and heat, protecting moisture-sensitive actives.
- Ribbon density control
- Fines recycling
- Compressibility
- Q4GranulationIntermediate
Loss on drying of granules is controlled because it affects:
Model answer: Moisture affects granule flow, compression behaviour, hardness and product stability.
- Target LOD range
- In-process check
- Impact on dissolution
- Q5CompressionIntermediate
Capping in tablets is usually caused by:
Model answer: Air entrapment during compression, insufficient binder or excessive compression force cause capping.
- Pre-compression force
- Dwell time
- Granule properties
- Q6CompressionIntermediate
Sticking on punch faces is best addressed by:
Model answer: Adjust lubrication, control moisture and use chrome-plated/embossed-punch design.
- Lubricant blend time
- Moisture control
- Punch maintenance
- Q7CompressionAdvanced
Over-lubrication with magnesium stearate typically causes:
Model answer: Excess hydrophobic lubricant forms a film reducing bonding and dissolution.
- Blend time control
- Lubricant %
- Dissolution monitoring
- Q8IPCBeginner
Which in-process check detects weight variation early?
Model answer: Periodic weight checks with control limits detect feeder or die-fill issues early.
- Defined frequency
- Control charts
- Action on trend
- Q9BlendingAdvanced
Content uniformity failure in a blend most likely indicates:
Model answer: Segregation during transfer or insufficient blend time causes uniformity failure.
- Blend uniformity sampling
- Transfer handling
- Particle size matching
- Q10BlendingAdvanced
Blend uniformity sampling should be taken:
Model answer: Stratified sampling at defined locations proves homogeneity across the blender.
- Sample thief technique
- Number of locations
- RSD criteria
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