Top QC Interview Questions / Answers
1) What is Quality Control (QC)?
Answer:
Quality Control ensures the quality of the product through testing of raw materials, in-process & finished products according to approved specifications and methods.
2) Difference Between QC and QA
| QC | QA |
|---|---|
| Test-based verification | System-based prevention |
| Ensures product quality | Ensures process quality |
| Reactive | Proactive |
| Works mainly in lab | Works plant-wide (Documents, SOP, GMP) |
3) What is HPLC?
Answer:
HPLC (High Performance Liquid Chromatography) is an analytical technique used to separate, identify & quantify components in a mixture.
Important Parameters: Flow Rate, Mobile Phase, Column Temp, Detector Type.
4) What is Retention Time (RT) in HPLC?
Answer:
The time at which a compound elutes from the column and appears on the chromatogram.
5) What is RSD and its limit?
Answer:
Relative Standard Deviation indicates precision of results.
Limit: Generally ≤ 2% for system suitability (may vary per method/specification).
6) What is System Suitability?
Answer:
A set of checks performed before sample analysis to ensure the system is performing correctly.
Examples: Plate Count, Tailing Factor, Retention Time Repeatability, RSD.
7) What is GC used for?
Answer:
GC (Gas Chromatography) is used for volatile and thermally stable compounds.
8) What is pH and how is pH meter calibrated?
Answer:
pH = Measure of acidity or alkalinity.
Calibration:
Usually performed with buffer solutions of pH 4.00, 7.00, and 9.20 / as per SOP.
9) What is a Stability Study?
Answer:
A study conducted to determine shelf life, storage conditions & degradation profile of the drug.
Types:
- Accelerated
- Long-term
- Intermediate
10) What is LOD and LOQ?
| Term | Meaning | Purpose |
|---|---|---|
| LOD | Limit of Detection | Minimum amount detectable but not quantifiable |
| LOQ | Limit of Quantification | Minimum amount that can be measured accurately |
11) What is GLP?
Answer:
Good Laboratory Practices — Ensures lab documentation, training, traceability, calibration & record integrity.
12) What is ALCOA?
Answer:
Data Integrity Principles:
Attributable
Legible
Contemporaneous
Original
Accurate
13) Why do we perform Calibration?
Answer:
To ensure instruments are giving accurate results compared to known standards.
14) What is Karl Fischer Titration used for?
Answer:
Used to determine water/moisture content in samples.
15) Describe Sampling of Raw Materials
- Check status label (Approved / Quarantine)
- Use clean sampling tools
- Perform sampling as per SOP & sampling plan
- Enter details in sampling logbook
Extra HR Question
Tell Me About Yourself (QC Profile)
Answer (Use This):
“I have knowledge/experience in HPLC, GC, Wet Chemistry, Stability Studies, LOD/LOQ, GLP, data documentation & lab safety practices. I follow GMP & ALCOA principles and ensure accurate reporting and compliance to specifications.”
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