Top cGMP Interview Questions and Answers

00:10 Section 1: Basic CGMP Concepts 1.Quality Assurance (QA), 2.In-Process Checks , 3. Documentation in CGMP, 4. Change Control , 5. Standard Operating Procedures (SOPs))
02:45 Section 2: Intermediate CGMP and Quality Control 6. Batch Manufacturing Record (BMR) 7. Difference Between BMR and BPR 8. Validation in CGMP 9. Calibration Importance 10. 21 CFR Part 11 Compliance01:30 Section 3: Advanced CGMP Processes 11. Positive Pressure in Manufacturing 12. Deviation in CGMP 13. Process Validation 14. Validation Master Plan (VMP) 15. Market Complaint05:33 Section 3: Advanced CGMP Processes 11. Positive Pressure in Manufacturing 12. Deviation in CGMP 13. Process Validation 14. Validation Master Plan (VMP) 15. Market Complaint
08:20 Section 4: Expert CGMP Topics 16. Product Recall 17. Vendor Qualification 18. Cleaning Validation 19. Annual Product Quality Review (APQR) 20. Critical Quality Attributes (CQAs)
Section 5: Advanced CGMP and Regulatory Compliance 21. Out of Specification (OOS) 22. Quality Risk Management (QRM) 23. Root Cause Analysis 24. Analytical Method Validation 25. Quality Management System (QMS)
Get ready to ace your CGMP interviews with this comprehensive guide on the most frequently asked questions in quality assurance, process validation, and regulatory compliance. This video covers essential topics you need to understand for a successful career in the pharmaceutical industry.🔍 Topics Covered in This Video:
1. Quality Assurance (QA) fundamentals
2. Key In-Process Checks during manufacturing
3. Importance of Documentation in CGMP
4. Change Control and its impact on quality
5. SOPs (Standard Operating Procedures)
6. Batch Manufacturing Records (BMR) & Batch Packaging Records (BPR) 7. Calibration and why it matters
8. 21 CFR Part 11 Compliance
9. Understanding Vendor Qualification
10. Cleaning Validation process
11. Environmental Monitoring & Quality Audits
12. Annual Product Quality Review (APQR)
13. Root Cause Analysis explained
and much more! Each question is designed to help you understand and apply CGMP principles effectively.📢

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