Top 10 interview questions about GLP , GDP & GMP practices.
1. What are GLP, GDP, and GMP, and how do they differ?
This foundational question tests your understanding of the definitions:
GLP: Ensures integrity and quality of non-clinical lab studies.
GDP: Ensures data integrity and accuracy in documentation.
GMP: Ensures products are consistently produced and controlled according to quality standards. Also, you should highlight the focus areas (lab, documentation, manufacturing) for each.
2. Why is GDP important in pharmaceutical documentation?
GDP maintains data integrity and traceability. Your answer should reflect the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available). Mistakes or poor documentation can lead to regulatory actions.
3. What are some examples of GDP violations?
This tests your practical knowledge. Examples include:
Using pencil instead of permanent ink
Backdating record
Illegible handwriting
Not signing entries
Failing to record activities in real-time
4. What is the significance of GLP in a laboratory setting?
GLP ensures reliable, reproducible, and auditable lab studies, especially for regulatory submissions. It governs things like equipment calibration, method validation, and sample traceability.
5. How do you handle deviations in GMP environments?
They’re assessing your approach to compliance and problem-solving. A strong answer would include:
Identifying and documenting the deviation
Notifying QA
Investigating root cause
Implementing CAPA (Corrective and Preventive Actions)
6. What are critical components of a GMP-compliant manufacturing facility?
You should touch on:
Controlled environments (e.g., cleanrooms)
SOPs
Trained personnel
Validated equipment and processes
Change control systems
QA oversight
7. How do GLP and GMP intersect in pharmaceutical product development?
GLP governs the preclinical (non-clinical) research phase, while GMP governs clinical trial material production and commercial manufacturing. This question checks your understanding of the regulatory timeline and transition between R&D and production.
8. What steps do you take to ensure documentation meets GDP standards?
You should mention:
Writing legibly with permanent ink
Documenting actions as they happen
Initialling and dating any corrections
Never leaving blank spaces
Storing records properly
9. What role does Quality Assurance (QA) play in GLP/GDP/GMP compliance?
QA ensures adherence to all three sets of practices. For example:
Reviewing data for integrity (GDP)
Auditing lab practices (GLP)
Monitoring manufacturing processes (GMP) QA acts as the independent compliance body within the organization.
10. Describe a situation where you identified and corrected a compliance issue.
This is a behavioral question. They’re looking for your hands-on experience, judgment, and initiative. Include:
• What the issue was
• How you identified it
• What steps you took to fix it
• What was learned from it
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