QC CHEMIST INTERVIEW

QUESTIONS AND ANSWER

Part 1
1. Can you explain what acceptance criteria means in the context of drug substances or products?

Answer: Acceptance criteria refers to the specific numerical limits, ranges, or other criteria that test
results for a drug substance, product, or other sample must adhere to in order to be considered
acceptable for its intended use.

2. How would you define accuracy in relation to test results?

Answer: Accuracy refers to the closeness of test results to the true value. It is a measure of how well the
testing process is able to produce results that are in line with the actual value of a substance or sample
being tested.

3. What does API or drug substance stand for, and how is it used in the manufacturing of drugs?

Answer: API stands for Active Pharmaceutical Ingredient or Drug Substance. It refers to any substance or
mixture of substances that is intended to be used in the manufacture of a drug product. When used in
drug production, the API becomes an active ingredient of the final drug product.

4. Could you explain what Analytical Instrument Qualification (AIQ) entails?

Answer: Analytical Instrument Qualification (AIQ) is the process of ensuring that an instrument is
suitable for its intended application. This involves verifying and documenting that the instrument meets
specific criteria and performance standards. AIQ is an important component of ensuring data quality,
along with software and analytical method validation, system suitability tests, and quality control tests.

5. What are the analytical performance characteristics that are assessed during method validation, and
how do they vary depending on the specific method and its intended use?

Answer: The analytical performance characteristics assessed during method validation include accuracy,
precision, linearity (range), limit of quantitation or detection, and robustness. The specific parameters
assessed may vary depending on the type of method and its intended use. For example, an assay
method would primarily focus on accuracy and precision.

6. What is the purpose of Analysis of Variance (ANOVA) in statistical testing?

Answer: Analysis of Variance (ANOVA) is a statistical test that measures the difference between the
means of groups of data. It is commonly used to determine if there are statistically significant
differences between the means of two or more groups. Unlike the t-test, which compares the means of
two groups, ANOVA allows for comparisons between multiple groups.
7. How would you define an assay in the context of content or potency?

Answer: An assay refers to an exact result that allows for an accurate assessment of the content or
potency of the analyte in a formulation. It is a quantitative measurement of the specific component
being analyzed, providing valuable information about its concentration or activity in a sample.

8. What is meant by assignable cause in the context of laboratory investigations following an out-of-
specification (OOS) result?

Answer: Assignable cause refers to the specific known cause that is determined through a laboratory
investigation following an out-of-specification (OOS) result. It could be a result of factors such as
operator error or instrument malfunction, and identifying the assignable cause is crucial in addressing
and resolving the issue.

9. How would you define asymmetry in relation to chromatographic peak shapes?

Answer: Asymmetry is a factor that describes the shape of a chromatographic peak. In theory, peak
shapes are described as Gaussian symmetrical. However, peak asymmetry refers to deviations from this
ideal shape. It is measured as the ratio of the distance between the peak apex and the back side of the
peak to the distance between the front side of the peak. A value greater than 1 indicates a tailing peak,
while a value less than 1 indicates a fronting peak.

10. Can you explain what an audit entails in terms of quality system compliance?

Answer: An audit is a documented independent review that is performed on a periodic basis to verify
compliance with a quality system. It involves examining processes, procedures, records, and other
relevant documentation to ensure that they adhere to established quality standards and regulatory
requirements.

11. Could you define what a batch refers to in the manufacturing context?

Answer: In the manufacturing context, a batch refers to a specific quantity of material that is produced
during one manufacturing cycle using the same specification. It ensures consistency in the production
process and allows for quality control measures to be applied to a defined quantity of product.

12. How would you define a biologic in the context of human treatment or disease prevention?

Answer: A biologic refers to a virus, therapeutic serum, toxin, antitoxin, or related substance that is used
for human treatment or disease prevention. Biologics are distinct from conventional chemical drugs and
are derived from living organisms or biological systems.
13. What are biological matrices, and could you provide examples of such matrices?

Answer: Biological matrices are samples of biological origin that are typically used for testing or analysis.
Examples of biological matrices include blood, serum, plasma, urine, feces, saliva, sputum, and tissues.
These matrices contain valuable information for analyzing and understanding various biological
processes and interactions.

14. Can you explain what biotechnology refers to?

Answer: Biotechnology refers to the use of living organisms or other biological systems in the
manufacture of drugs or other products or for environmental management. It involves utilizing
biological processes, organisms, or biomolecules to develop or improve products and applications, such
as the production of genetically modified organisms or the use of enzymes in industrial processes.

15. How would you define a blank in the context of analytical methods?

Answer: In the context of analytical methods, a blank refers to a sample that does not include the
analytes of interest. It is used to assess the specificity of a method by determining if there is any
interference or contribution from other components present in the sample matrix. Examples of blanks
include mobile phase, diluent, and procedural blanks.

16. What is the purpose of calibration in analytical testing?

Answer: Calibration ensures that an instrument's response correlates with the response of the standard
or reference material. It involves comparing the instrument's measurements to known standards of
known concentration or value to establish a relationship between the instrument's response and the
actual quantity or property being measured. Calibration should be carried out following documented
written and approved procedures, using traceable certified standards.

17. How would you define capacity factor in chromatography?

Answer: Capacity factor (kʹ) is a chromatographic parameter that measures the degree of retention. It is
calculated using the equation: kʹ = (tR − t0)/t0, where tR is the retention time and t0 is the retention
time of an unretained peak. The capacity factor provides information about how well the analyte is
retained on the stationary phase of the chromatographic column.

18. What is the purpose of certification, and how is it documented?

Answer: Certification refers to a documented statement or written guarantee by qualified individuals

that an instrument, computer, test, or system complies with specified requirements. It provides
assurance that the instrument or system has been tested and meets the necessary standards.
Certification is typically documented through written certificates or reports that detail the outcome of
the certification process.

19. What does cGMP stand for, and where can it be found in the Code of Federal Regulations?

Answer: cGMP stands for Current Good Manufacturing Practice. It refers to the regulations and
guidelines that govern the manufacturing, testing, and quality control of pharmaceutical products. The
specific requirements can be found in Title 21, Code of Federal Regulations, Section 210, 211, and 212.
These regulations outline the standards that pharmaceutical manufacturers must adhere to in order to
ensure the safety, effectiveness, and quality of their products.