[GlobalGMP] GLOBALG M P Certificate
Certification Review Guide
Question 1. Which regulatory agency is primarily responsible for enforcing GMP standards in the
United States?
A) EMA
B) MHRA
C) FDA
D) WHO
Answer: C
Explanation: The U.S. Food and Drug Administration (FDA) enforces GMP regulations under
21 CFR 210‑211 for pharmaceuticals.
Question 2. The European Medicines Agency (EMA) collaborates with which of the following to
harmonize GMP across Europe?
A) CDC
B) EMEA
C) EU Member State authorities
D) FDA
Answer: C
Explanation: EMA works with national competent authorities of EU Member States to ensure
consistent GMP implementation.
Question 3. What does the “c” in cGMP stand for?
A) Certified
B) Continuous
C) Current
D) Comprehensive
Answer: C
, [GlobalGMP] GLOBALG M P Certificate
Certification Review Guide
Explanation: cGMP means “current Good Manufacturing Practice,” emphasizing that practices
must reflect up‑to‑date technology and knowledge.
Question 4. Which of the following is NOT one of the 5 P’s of GMP?
A) People
B) Products
C) Processes
D) Patents
Answer: D
Explanation: The 5 P’s are People, Products, Procedures, Processes, and Premises; patents are
unrelated.
Question 5. The “Thalidomide disaster” primarily highlighted the need for stricter control of
which GMP element?
A) Equipment qualification
B) Documentation integrity
C) Product labeling
D) Personnel hygiene
Answer: B
Explanation: Inadequate documentation and testing allowed a teratogenic drug to reach
market, prompting stronger data integrity requirements.
Question 6. Which document defines the overall quality policy and objectives of an
organization?
A) SOP
B) Quality Manual
C) Batch Record
, [GlobalGMP] GLOBALG M P Certificate
Certification Review Guide
D) Change Control Form
Answer: B
Explanation: The Quality Manual outlines the quality system, policies, and objectives.
Question 7. A deviation that occurs during a manufacturing run is best managed through which
process?
A) CAPA
B) Change Control
C) Deviation Management
D) Supplier Qualification
Answer: C
Explanation: Deviation Management investigates and documents unexpected events during
production.
Question 8. The root cause analysis step in CAPA is primarily intended to:
A) Implement immediate corrective actions only
B) Identify underlying reasons for a non‑conformance
C) Approve a new supplier
D) Update the quality manual
Answer: B
Explanation: CAPA’s purpose is to find and eliminate the underlying cause to prevent
recurrence.
Question 9. ICH Q9 focuses on which of the following?
A) Validation of analytical methods
B) Quality risk management
, [GlobalGMP] GLOBALG M P Certificate
Certification Review Guide
C) Stability testing guidelines
D) Data integrity standards
Answer: B
Explanation: ICH Q9 provides a framework for risk‑based decision making throughout the
product lifecycle.
Question 10. Which role is legally responsible for certifying that each batch of a medicinal
product meets all regulatory requirements before release?
A) Head of Production
B) Qualified Person (QP)
C) Head of Quality Control
D) Regulatory Affairs Manager
Answer: B
Explanation: In the EU, the QP signs the batch release certificate confirming compliance.
Question 11. The initial GMP training provided to all new employees is known as:
A) Refresher training
B) Induction training
C) On‑the‑job training
D) Auditing training
Answer: B
Explanation: Induction training introduces new hires to GMP principles and site‑specific
requirements.
Question 12. Which of the following best describes the purpose of personnel hygiene protocols
in cleanrooms?
Certification Review Guide
Question 1. Which regulatory agency is primarily responsible for enforcing GMP standards in the
United States?
A) EMA
B) MHRA
C) FDA
D) WHO
Answer: C
Explanation: The U.S. Food and Drug Administration (FDA) enforces GMP regulations under
21 CFR 210‑211 for pharmaceuticals.
Question 2. The European Medicines Agency (EMA) collaborates with which of the following to
harmonize GMP across Europe?
A) CDC
B) EMEA
C) EU Member State authorities
D) FDA
Answer: C
Explanation: EMA works with national competent authorities of EU Member States to ensure
consistent GMP implementation.
Question 3. What does the “c” in cGMP stand for?
A) Certified
B) Continuous
C) Current
D) Comprehensive
Answer: C
, [GlobalGMP] GLOBALG M P Certificate
Certification Review Guide
Explanation: cGMP means “current Good Manufacturing Practice,” emphasizing that practices
must reflect up‑to‑date technology and knowledge.
Question 4. Which of the following is NOT one of the 5 P’s of GMP?
A) People
B) Products
C) Processes
D) Patents
Answer: D
Explanation: The 5 P’s are People, Products, Procedures, Processes, and Premises; patents are
unrelated.
Question 5. The “Thalidomide disaster” primarily highlighted the need for stricter control of
which GMP element?
A) Equipment qualification
B) Documentation integrity
C) Product labeling
D) Personnel hygiene
Answer: B
Explanation: Inadequate documentation and testing allowed a teratogenic drug to reach
market, prompting stronger data integrity requirements.
Question 6. Which document defines the overall quality policy and objectives of an
organization?
A) SOP
B) Quality Manual
C) Batch Record
, [GlobalGMP] GLOBALG M P Certificate
Certification Review Guide
D) Change Control Form
Answer: B
Explanation: The Quality Manual outlines the quality system, policies, and objectives.
Question 7. A deviation that occurs during a manufacturing run is best managed through which
process?
A) CAPA
B) Change Control
C) Deviation Management
D) Supplier Qualification
Answer: C
Explanation: Deviation Management investigates and documents unexpected events during
production.
Question 8. The root cause analysis step in CAPA is primarily intended to:
A) Implement immediate corrective actions only
B) Identify underlying reasons for a non‑conformance
C) Approve a new supplier
D) Update the quality manual
Answer: B
Explanation: CAPA’s purpose is to find and eliminate the underlying cause to prevent
recurrence.
Question 9. ICH Q9 focuses on which of the following?
A) Validation of analytical methods
B) Quality risk management
, [GlobalGMP] GLOBALG M P Certificate
Certification Review Guide
C) Stability testing guidelines
D) Data integrity standards
Answer: B
Explanation: ICH Q9 provides a framework for risk‑based decision making throughout the
product lifecycle.
Question 10. Which role is legally responsible for certifying that each batch of a medicinal
product meets all regulatory requirements before release?
A) Head of Production
B) Qualified Person (QP)
C) Head of Quality Control
D) Regulatory Affairs Manager
Answer: B
Explanation: In the EU, the QP signs the batch release certificate confirming compliance.
Question 11. The initial GMP training provided to all new employees is known as:
A) Refresher training
B) Induction training
C) On‑the‑job training
D) Auditing training
Answer: B
Explanation: Induction training introduces new hires to GMP principles and site‑specific
requirements.
Question 12. Which of the following best describes the purpose of personnel hygiene protocols
in cleanrooms?
