19+ Top Pharma Quality Control (QC) Interview Questions and Answers

Pharma Quality Control (QC) FAQS

To face a Pharma Quality Control (QC) Interview is a challenging task, and it needs both skill and knowledge of analytical chemistry. It plays a vital role in the pharmaceutical industry since it ensures the safety, efficacy, and quality of the drug. Whether you’re preparing for an entry-level or experienced QC role, understanding key concepts, instruments, and regulatory requirements is essential. That is why I decided to share my experience on this topic. This list of common Pharma QC interview questions and answers will help you confidently prepare for your interview and demonstrate your knowledge effectively.

What is Quality Control (QC) in pharmaceuticals?

Answer:
Quality Control ensures that pharmaceutical products meet specified standards for identity, strength, purity, and quality through analytical testing of raw materials, in-process samples, and finished products.

2. What is the difference between QA and QC?

Answer:

• QA: Prevents defects (process-oriented)
• QC: Detects defects (product-oriented)

3. What are common instruments used in QC labs?

Answer:

• HPLC (High-Performance Liquid Chromatography)
• UV-Vis Spectrophotometer
• GC (Gas Chromatography)
• FTIR (Fourier-Transform Infrared Spectroscopy)
• pH Meter, Karl Fischer Titrator, Dissolution Tester

4. What is HPLC, and why is it used?

Answer:
HPLC is an analytical technique used to separate, identify, and quantify components in a mixture. It’s widely used for assay and impurity profiling.

5. What is the purpose of system suitability in HPLC?

Answer:
To ensure the system’s performance before sample analysis. Parameters like theoretical plates, resolution, and tailing factor must meet set criteria.

6. What is LOD and LOQ?

Answer:

• LOD (Limit of Detection): Lowest amount detectable, not necessarily quantifiable.
• LOQ (Limit of Quantitation): Lowest amount that can be quantitatively determined with acceptable accuracy and precision.

7. What is the difference between assay and purity?

Answer:

• Assay: Measures the active ingredient content.
• Purity: Detects the level of impurities present.

8. What is method validation?

Answer:
It is the process of proving that an analytical method is suitable, accurate, precise, specific, linear, and robust for its intended purpose.

9. What are the types of analytical method validation?

Answer:

• Specificity
• Linearity
• Accuracy
• Precision
• LOD & LOQ
• Robustness
• Ruggedness

10. What is a stability study?

Answer:
A study to determine how the quality of a drug varies with time under the influence of environmental factors like temperature, humidity, and light.

11. What is a chromatographic peak tailing?

Answer:
A distortion where the peak stretches on the right side. Acceptable tailing factor is ≤ 2.0.

12. What are GMP requirements in QC?

Answer:

• Good documentation practices
• Equipment calibration & maintenance
• Analytical method validation
• Proper sample handling and storage
• Data integrity

13. What is OOS and how is it handled?

Answer:
OOS (Out of Specification) is when test results fall outside the predefined specs.
Handled via:

• Immediate investigation
• Root cause analysis
• Retesting/reanalysis as per SOP

14. What is the role of calibration in QC?

Answer:
To ensure instruments provide accurate and reliable results. Calibration must be done at defined intervals and recorded.

15. What are common QC documents?

Answer:

• COA (Certificate of Analysis)
• STP (Standard Testing Procedure)
• SOP (Standard Operating Procedure)
• Calibration & Validation Reports
• Logbooks and Test Records

16. What is QC in pharma?

Answer:

QC (Quality Control) in pharma is the process of testing and verifying that pharmaceutical products meet specified quality standards for safety, efficacy, and purity before release.

17. What is QC and its types in pharma?

QC is the process of monitoring and testing raw materials, in-process samples, and finished pharmaceutical products to ensure they meet predefined quality standards and regulatory requirements.

Types of QC in Pharma:

1. Raw Material Testing:
   Ensures incoming materials meet specifications before use.
2. In-Process Testing:
   Checks quality during manufacturing to control the process.
3. Finished Product Testing:
   Confirms final products comply with quality standards before release.
4. Stability Testing:
   Assesses product quality over time under different environmental conditions.
5. Microbiological Testing:
   Detects and controls microbial contamination.

18. What is the salary of QC in Pharma? short answer

The average salary of a QC professional in pharma varies by experience and location, but typically ranges from ₹ 500000 to ₹5000000 per year for entry to mid-level positions. Senior roles can earn more.

19. Is QC a good career?

Yes

20. What is the full form of QC?

Answer:

Quality control

Conclusion

A solid grasp of Quality Control principles, techniques, and regulations is vital for success in pharmaceutical QC roles. Preparing answers to common interview questions will boost your confidence and showcase your readiness to maintain high-quality standards in the industry.