Production and GMP interview questions (with answers)
20 original interview questions with answers for pharma production freshers and candidates with up to 3 years of experience: line clearance, dispensing, granulation, compression, IPQC, cleaning and revised Schedule M. Tap an option to check your answer, or open "Show answer".
1. What is the main purpose of line clearance?
Show answer
Answer: C — Line clearance prevents mix-ups and cross-contamination by confirming that everything from the earlier batch has been removed before a new one starts. It is documented and verified, normally by QA.
2. When must line clearance be done?
Show answer
Answer: A — Line clearance is a routine check at the start of a batch, at product changeovers and between key stages. It applies to manufacturing and packaging.
3. What must the dispensing operator check before weighing a raw material?
Show answer
Answer: B — Only materials released by QC may be dispensed, and the identity and quantity are verified and recorded. A second-person check on identity and weight reduces the risk of wrong material or quantity (example in-house practice).
4. What does FEFO mean in material dispensing and storage?
Show answer
Answer: D — FEFO means stock with the earliest expiry or retest date is used first. It differs from FIFO, which follows receipt date and can be risky when a later batch expires earlier.
5. What is the main purpose of wet granulation in tablet manufacturing?
Show answer
Answer: A — Binding fine particles into granules gives better flow, more uniform die filling and better compaction, and the drug and excipients stay mixed during handling.
6. Why is Loss on Drying (LOD) of granules checked after drying?
Show answer
Answer: C — Granules that are too wet stick and can degrade the drug, while granules that are too dry produce capping and poor binding. The acceptable LOD range comes from the approved process.
7. What is a likely effect of excessive blending time with magnesium stearate?
Show answer
Answer: B — Magnesium stearate is hydrophobic and over-mixing spreads it as a film around the granules, which weakens bonding and slows wetting. That is why the lubrication step has a defined blending time.
8. Which of the following is a common cause of capping in tablets?
Show answer
Answer: D — Capping is the separation of the top of the tablet and can be caused by air trapped during compression, too many fines, too little binder or too fast a press speed. Corrective action may include granule moisture, pre-compression or machine speed adjustments.
9. In film coating, what is a typical cause of tablets sticking together or picking in the pan?
Show answer
Answer: A — If the coating liquid is applied faster than it can evaporate, tablets become tacky and stick to each other or to the pan. Reducing spray rate or increasing inlet air temperature and airflow within the validated range helps.
10. What does the hardness test measure?
Show answer
Answer: C — Hardness (crushing strength) is checked in process to make sure tablets will survive handling but still disintegrate. The limit comes from the approved batch manufacturing record, not from a general pharmacopoeial value.
11. What does the friability test indicate?
Show answer
Answer: B — Tablets are weighed, tumbled in a friabilator for a set number of rotations, de-dusted and weighed again. Greater weight loss means weaker tablets that can chip during coating, packing or transport.
12. Which description fits the disintegration test apparatus?
Show answer
Answer: D — Disintegration shows whether a tablet breaks into particles within a specified time in a defined medium. The paddle apparatus belongs to dissolution testing, and the tumbling drum is the friabilator.
13. Why is weight variation checked during compression?
Show answer
Answer: A — For a uniform blend, tablet weight is a quick in-process indicator of how much drug each tablet contains. It does not replace content uniformity or assay testing.
14. Which information is normally shown on an equipment status label?
Show answer
Answer: C — A status label tells everyone at a glance whether the equipment may be used and what it last handled. The exact format is decided by the site (example in-house practice).
15. What is "clean hold time" for equipment?
Show answer
Answer: B — Cleaned equipment can pick up dust and microbes over time. The hold time is justified in cleaning validation and stated in the SOP (example in-house practice for the actual duration).
16. How should an entry be made in an equipment logbook?
Show answer
Answer: D — Logs must be contemporaneous, attributable and legible, so that use, cleaning and maintenance history can be reconstructed. Pencil, back-filling and overwriting breach good documentation practice.
17. What is yield reconciliation?
Show answer
Answer: A — Reconciliation of yield at defined stages shows whether material has been lost, mixed up or added unexpectedly. Results outside the limits in the batch record are investigated before the batch moves on or is released.
18. What is the correct way to correct a mistake in a batch manufacturing record?
Show answer
Answer: C — The original entry must remain readable so that the correction can be reviewed. Correction fluid, over-writing and removing pages hide what was originally recorded and are data-integrity failures.
19. How was the revised Schedule M (GMP) published in India?
Show answer
Answer: B — The Ministry of Health and Family Welfare notified the revised Schedule M under the Drugs Rules, 1945, so it is part of Indian law and not merely a recommendation. Phase-in dates depend on the manufacturer's category, so check the official notification for dates.
20. Which of the following is a feature that the revised Schedule M places stronger emphasis on than the earlier version?
Show answer
Answer: D — The revised Schedule M brings the Indian GMP text closer to current international practice, including a pharmaceutical quality system, quality risk management and product quality review. It does not remove documentation or independent quality oversight.