“Preparation builds confidence. Confidence improves performance.”
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
64–80 Examples
- How do you reduce deviations?
- How do you manage CAPAs?
- How do you prepare for inspections?
- How do you improve OEE?
- How do you manage underperforming employees?
- How do you prioritize multiple projects?
- How do you handle audit observations?
PART P: SCENARIO-BASED QUESTIONS
81. 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.
82. FDA inspector identifies data integrity concern. What will you do?
Model Answer
- Acknowledge observation.
- Gather facts.
- Initiate investigation.
- Assess impact.
- Implement CAPA.