Certificate in GMP (Good Manufacturing Practice) FAQs
What is the format of the exam?
The exam includes 60 multiple‑choice questions and 5 scenario‑based case studies. You have 90 minutes to complete it.
Who should take the exam?
Professionals in quality, production, validation, compliance, and regulatory roles within regulated manufacturing.
Is prior GMP experience required?
Foundational knowledge of manufacturing procedures is helpful, but the exam covers GMP fundamentals and applications.
How can I prepare?
Review GMP regulations (e.g., FDA, EMA), study SOPs and validation protocols, and practice case studies on deviation and CAPA management.
What score is required to pass?
A minimum score of 70% overall is required to earn certification.
Can I retake the exam if I fail?
Yes. You may retake it after a 14‑day waiting period.
How long is certification valid?
Certification remains valid for three years. Renewal requires completing a refresher assessment on updated GMP guidelines.
What tools do I need for the exam?
A scientific calculator and access to GMP reference materials; no special software is needed during the test.
Are practical tasks included?
Yes. Scenario‑based case studies test your ability to handle deviations, perform risk assessments, and propose CAPA.
How will this certification benefit me?
It validates your GMP expertise, enhancing credibility for roles in quality assurance, production management, and regulatory compliance.