Manufacturing and quality

Good Manufacturing Practice (GMP) interview questions

Controlled manufacturing, documentation and quality risk management.

9 questions, each with a worked answer

What is the difference between a deviation and a change control? Fundamentals Concept
How would you investigate a GMP deviation? Intermediate Scenario
Why can a completed batch record still contain a major data integrity risk? Advanced Concept
When does a manufacturing change require validation review? Advanced Scenario
What makes a root cause scientifically defensible? Advanced Concept
How do you distinguish correction, corrective action and preventive action? Intermediate Scenario
How would you assess whether an undocumented manual correction affects the integrity of a batch record? Intermediate Troubleshooting
An environmental monitoring excursion occurs during production. How would you investigate affected lots? Intermediate Scenario
Design controls for a high-risk manual material addition to a GMP process. Advanced Practical

About Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP) is the set of rules that makes sure medicines are consistently produced and controlled to their quality standards. It covers facilities, equipment, materials, processes, documentation and the people doing the work. Its core idea is that quality is built into each step rather than tested in at the end.

Anyone working in manufacturing, quality or supply of medicines works under it.

Fundamentals: 1
Intermediate: 4
Advanced: 4

What these questions test

Execute GMP documentation: Complete controlled records contemporaneously and flag deviations.

References

Current Good Manufacturing Practice (CGMP) Regulations. U.S. Food and Drug Administration. fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations.
fda.gov/regulatory-information/search-fda-guidance-documents/q10-pharmaceutical-quality-system.
fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers.
fda.gov/regulatory-information/search-fda-guidance-documents/process-validation-general-principles-and-practices.
ema.europa.eu/en/scientific-guidelines/ich-q9-quality-risk-management.
fda.gov/media/71026/download.

Practice material written by TheBench.Bio and checked against the references above, reviewed October 23, 2026. Written to practise with, not collected from real interviews.