PART A: GMP FUNDAMENTALS
1. What is GMP?
Answer:
Good Manufacturing Practices (GMP) are regulations and guidelines that ensure pharmaceutical products are consistently produced and controlled according to quality standards appropriate for their intended use.
Key Objectives:
- Patient Safety
- Product Quality
- Regulatory Compliance
2. What are the five P’s of GMP?
Answer:
- People
- Premises
- Processes
- Procedures
- Products
These elements collectively ensure product quality and compliance.
3. What is GDP?
Answer:
Good Documentation Practices ensure that records are:
- Accurate
- Legible
- Contemporaneous
- Complete
- Traceable
GDP supports data integrity and regulatory compliance.
4. What is ALCOA+?
Answer:
ALCOA+ Principles:
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
Plus:
- Complete
- Consistent
- Enduring
- Available
5. Why is GMP important?
Answer:
GMP ensures:
- Patient safety
- Product consistency
- Regulatory compliance
- Prevention of contamination and errors
PART B: DEVIATIONS, INVESTIGATIONS & CAPA
6. What is a Deviation?
Answer:
A deviation is any departure from:
- Approved procedures
- Specifications
- GMP requirements
- Established standards
7. What are the types of deviations?
Answer:
- Minor
- Major
- Critical
Classification depends on product quality and patient impact.
8. What is Root Cause Analysis?
Answer:
RCA is a systematic method used to identify the true underlying cause of a problem.
Tools include:
- 5 Why Analysis
- Fishbone Diagram
- Fault Tree Analysis
9. What is CAPA?
Answer:
CAPA stands for:
Corrective Action and Preventive Action.
Corrective Action:
Eliminates existing problems.
Preventive Action:
Prevents recurrence.
10. What is CAPA Effectiveness Verification?
Answer:
A documented assessment confirming that CAPA successfully prevented recurrence.
PART C: OOS & OOT
11. What is OOS?
Answer:
Out of Specification result.
A test result outside approved specification limits.
12. What is OOT?
Answer:
Out of Trend result.
A result within specification but inconsistent with historical trends.
13. What are common causes of OOS?
Answer:
- Analyst errors
- Instrument issues
- Sample preparation errors
- Product quality issues
- Method-related problems
14. What should be done when OOS occurs?
Answer:
- Stop release
- Initiate investigation
- Evaluate laboratory causes
- Evaluate manufacturing causes
- Document findings
PART D: CHANGE CONTROL
15. What is Change Control?
Answer:
A formal process used to evaluate, approve, implement, and document changes that may affect product quality or compliance.
16. Why is Change Control important?
Answer:
It prevents unintended consequences and maintains validated state.
17. What changes typically require Change Control?
Answer:
- Equipment changes
- Process changes
- Facility modifications
- Software changes
- Specification changes
PART E: QUALITY RISK MANAGEMENT
18. What is Quality Risk Management?
Answer:
A systematic process for:
- Identifying risks
- Assessing risks
- Controlling risks
- Reviewing risks
19. What is FMEA?
Answer:
Failure Mode and Effects Analysis.
A structured risk assessment tool.
20. What is Risk Priority Number (RPN)?
Answer:
RPN = Severity × Occurrence × Detection
Used to prioritize risks.
PART F: PROCESS VALIDATION
21. What is Process Validation?
Answer:
Documented evidence that a process consistently produces products meeting predetermined specifications.
22. What are validation stages?
Answer:
- Process Design
- Process Qualification
- Continued Process Verification
23. What is PPQ?
Answer:
Process Performance Qualification.
Commercial-scale validation batches demonstrating process consistency.
24. Why is Process Validation important?
Answer:
To ensure:
- Product quality
- Process consistency
- Regulatory compliance
PART G: CLEANING VALIDATION
25. What is Cleaning Validation?
Answer:
Documented evidence that cleaning procedures effectively remove residues to acceptable levels.
26. What are common acceptance criteria?
Answer:
- Visual cleanliness
- Chemical residue limits
- Microbial limits
27. What is Worst Case Product?
Answer:
Product presenting highest cleaning challenge based on toxicity, solubility, potency, and cleanability.
PART H: DATA INTEGRITY
28. What is Data Integrity?
Answer:
Data must be complete, consistent, accurate, and reliable throughout its lifecycle.
29. Why are audit trails important?
Answer:
They record:
- Who performed actions
- What changed
- When changes occurred
30. What are common Data Integrity violations?
Answer:
- Shared passwords
- Backdating
- Unrecorded activities
- Unauthorized data changes
PART I: QA INTERVIEW QUESTIONS
31. What is APQR?
Answer:
Annual Product Quality Review.
A periodic evaluation of product and process performance.
32. What is a Quality Management System?
Answer:
A structured system ensuring product quality and compliance.
33. What is Batch Release?
Answer:
Formal QA approval allowing product distribution.
34. What is Line Clearance?
Answer:
Verification that an area is free from materials, documents, and products from previous operations.
35. Why are investigations important?
Answer:
To identify root causes and prevent recurrence.
PART J: QC INTERVIEW QUESTIONS
36. What is HPLC?
Answer:
High Performance Liquid Chromatography used for separation and analysis of compounds.
37. What is System Suitability?
Answer:
Verification that analytical systems are functioning properly before testing.
38. What is Calibration?
Answer:
Comparison of an instrument against a known standard.
39. Difference Between Accuracy and Precision?
Answer:
Accuracy = Closeness to true value.
Precision = Reproducibility of results.
40. What is Method Validation?
Answer:
Demonstrating analytical methods are suitable for intended use.
PART K: PRODUCTION INTERVIEW QUESTIONS
41. What is BMR?
Answer:
Batch Manufacturing Record.
Complete record of manufacturing activities.
42. What is Yield?
Answer:
Actual output compared to theoretical output.
Yield(%)=Theoretical OutputActual Output×100
43. What is FTR?
Answer:
First Time Right.
Doing work correctly the first time without rework.
44. What is Hold Time?
Answer:
Maximum allowable time between manufacturing stages.
45. What is Compression Force?
Answer:
Force applied during tablet compression affecting hardness and quality.
PART L: VALIDATION INTERVIEW QUESTIONS
46. What is IQ?
Answer:
Installation Qualification.
47. What is OQ?
Answer:
Operational Qualification.
48. What is PQ?
Answer:
Performance Qualification.
49. What is VMP?
Answer:
Validation Master Plan.
50. What is CSV?
Answer:
Computer System Validation.
PART M: ENGINEERING QUESTIONS
51–60 Key Topics
- HVAC
- Pressure Differentials
- HEPA Filters
- Preventive Maintenance
- Breakdown Maintenance
- Calibration
- Utilities
- WFI Systems
- Compressed Air
- Clean Steam
PART N: LEADERSHIP QUESTIONS
61. Describe your leadership style.
Model Answer:
“I focus on coaching, accountability, team development, and continuous improvement while maintaining strong GMP compliance.”
62. How do you manage conflict?
Model Answer:
“I address issues early, listen to all perspectives, identify root causes, and seek mutually beneficial solutions.”
63. How do you motivate your team?
Model Answer:
“Through recognition, coaching, involvement in decisions, and opportunities for development.”
PART O: MANAGERIAL QUESTIONS
PART P: SCENARIO-BASED QUESTIONS
64. A critical deviation occurs before product release. What will you do?
Model Answer
- Stop release.
- Assess impact.
- Investigate root cause.
- Implement CAPA.
- Evaluate product disposition.
65. FDA inspector identifies data integrity concern. What will you do?
Model Answer
- Acknowledge observation.
- Gather facts.
- Initiate investigation.
- Assess impact.
- Implement CAPA.
About the Author
Ramesh Palav is a GxP Compliance and Computer System Validation (CSV) professional with experience in pharmaceutical manufacturing, quality systems, data integrity, and digital transformation. He is passionate about helping organizations adopt compliant, efficient, and practical digital solutions while maintaining regulatory expectations and patient safety.