quality control interview preparation

1. What is Quality Control (QC) in the pharmaceutical industry?

Answer:
Quality Control (QC) is the process of testing pharmaceutical products and raw materials to ensure they meet predefined quality standards. QC involves sampling, testing, and documentation to verify compliance with regulatory requirements such as Good Manufacturing Practice (GMP), ICH guidelines, and USP/BP standards.

2. What is the difference between Quality Control (QC) and Quality Assurance (QA)?

Answer:

Quality Control (QC)Quality Assurance (QA)QC focuses on detecting defects.QA focuses on preventing defects.Involves testing of raw materials, in-process samples, and finished products.Involves process monitoring, audits, and documentation.Reactive approach.Proactive approach.Part of the manufacturing process.Encompasses the entire pharmaceutical process.

3. What are the responsibilities of a QC analyst?

Answer:
A QC analyst is responsible for:

• Conducting analytical tests on raw materials, intermediates, and finished products.

• Performing instrumental analysis (HPLC, UV, IR, GC, etc.).

• Ensuring compliance with pharmacopeial standards (USP, BP, IP).

• Preparing and maintaining test reports and documentation.

• Conducting stability studies and calibration of lab instruments.

4. What is Good Laboratory Practice (GLP)?

Answer:
Good Laboratory Practice (GLP) is a set of principles ensuring that laboratory studies are planned, performed, monitored, and reported accurately. It focuses on:

• Proper documentation and data integrity.

• Instrument calibration and validation.

• Standard Operating Procedures (SOPs).

• Staff training and qualifications.

5. What is a pharmacopeia? Name a few pharmacopeias used worldwide.

Answer:
A pharmacopeia is an official book containing drug standards, tests, and specifications. Some commonly used pharmacopeias are:

• USP (United States Pharmacopeia)

• BP (British Pharmacopeia)

• IP (Indian Pharmacopeia)

• EP (European Pharmacopeia)

• JP (Japanese Pharmacopeia)

6. What are the different types of analytical techniques used in QC?

Answer:
Common analytical techniques in QC include:

• Chromatography (HPLC, GC, TLC).

• Spectroscopy (UV-Vis, IR, NMR, AAS).

• Titration (Karl Fischer, Acid-base, Complexometric).

• Dissolution Testing (for tablets & capsules).

• Loss on Drying (LOD) & Moisture Content (for raw materials).

7. What is High-Performance Liquid Chromatography (HPLC)?

Answer:
HPLC is an analytical technique used for separating, identifying, and quantifying components in pharmaceutical samples. It consists of:

• Mobile Phase (solvent moving the sample).

• Stationary Phase (column packing material).

• Detector (UV, PDA, Fluorescence).

• Pump (to maintain flow).

8. What is the difference between HPLC and Gas Chromatography (GC)?

Answer:

HPLCGCUsed for liquid samples.Used for volatile and gaseous samples.Mobile phase: Liquid solvents.Mobile phase: Carrier gas (e.g., helium, nitrogen).Widely used for drugs, proteins, and biomolecules.Used for essential oils, gases, and organic solvents.

9. What is Karl Fischer Titration?

Answer:
Karl Fischer Titration is a moisture determination technique used in pharmaceuticals. It measures water content using a chemical reaction between iodine, sulfur dioxide, and water. It is widely used in API and excipient analysis.

10. What is FTIR (Fourier Transform Infrared Spectroscopy)?

Answer:
FTIR is an analytical technique used to identify functional groups in molecules by measuring their infrared absorption. It is commonly used in raw material identification and impurity profiling.

11. What is an Out-of-Specification (OOS) result?

Answer:
An OOS result occurs when a test result falls outside the approved specification limits. The procedure for handling OOS includes:

1. Initial Investigation – Checking instrument calibration, sample preparation, and analyst error.

2. Confirmatory Testing – Retesting the sample using a new preparation.

3. CAPA Implementation – Identifying and correcting root causes.

12. What is Out-of-Trend (OOT)?

Answer:
OOT refers to test results that are within specification but show an unexpected trend or variation when compared to previous data. It helps in early detection of potential issues in product stability.

13. What is stability testing?

Answer:
Stability testing evaluates how environmental factors (temperature, humidity, light) affect a pharmaceutical product over time. It helps determine the shelf life and storage conditions. Types of stability testing include:

• Long-term stability (Normal conditions).

• Accelerated stability (High temperature & humidity).

• Intermediate stability (Moderate stress conditions).

14. What is an impurity in pharmaceuticals? How is it classified?

Answer:
Impurities are unwanted substances present in a drug product. They are classified as:

• Organic Impurities (process-related, degradation products).

• Inorganic Impurities (heavy metals, residual catalysts).

• Residual Solvents (left from synthesis, e.g., ethanol, methanol).

15. How would you handle a deviation during testing?

Answer:

1. Stop the analysis immediately.

2. Inform the QC supervisor.

3. Document the deviation in the laboratory logbook.

4. Investigate the root cause (instrument, sample, analyst error).

5. Implement corrective actions and retest if necessary.

16. Why do you want to work in Quality Control?

Answer:
"I am passionate about ensuring drug safety and efficacy. Quality Control plays a vital role in maintaining pharmaceutical standards, ensuring patient safety, and regulatory compliance. I am eager to contribute by applying my analytical skills and knowledge of QC techniques."

17. What are your strengths that make you a good fit for QC?

Answer:

• Attention to detail (ensuring test accuracy).

• Analytical skills (handling instruments like HPLC, UV).

• Regulatory knowledge (GMP, GLP, pharmacopeias).

• Problem-solving (investigating OOS/OOT results).

18. Where do you see yourself in five years in the pharmaceutical industry?

Answer:
"In five years, I see myself as an experienced Quality Control Analyst, contributing to regulatory audits, analytical method validation, and process improvements in the pharmaceutical sector."