[GMP] GMP GOOD MANUFACTURING
PRACTICES Certification Review Guide
**Question 1. Which element of a Quality Management System (QMS) defines the
organization’s commitment to product safety and efficacy?**
A) Standard Operating Procedures (SOPs)
B) Quality Policy
C) Batch Production Record (BPR)
D) Calibration schedule
Answer: B
Explanation: The Quality Policy is a formal statement that expresses top‑management’s
commitment to safety, efficacy, and compliance, forming the foundation of the QMS.
**Question 2. In the hierarchy of GMP documentation, which document provides the highest
level of detail for day‑to‑day operations?**
A) Quality Manual
B) SOP
C) Work Instruction
D) Record
Answer: C
Explanation: Work Instructions break down SOPs into step‑by‑step actions for operators,
offering the most detailed guidance.
**Question 3. What is the primary purpose of a Change Control procedure?**
A) To approve new product formulations only
B) To manage any modification to processes, equipment, or materials in a controlled manner
C) To document employee training records
D) To schedule routine equipment maintenance
Answer: B
, [GMP] GMP GOOD MANUFACTURING
PRACTICES Certification Review Guide
Explanation: Change Control ensures that any alteration is evaluated for impact on product
quality and compliance before implementation.
**Question 4. Which of the following best describes a corrective action in a CAPA system?**
A) Identifying a potential future risk
B) Eliminating the cause of a detected non‑conformance
C) Training staff on new procedures
D) Updating the quality manual
Answer: B
Explanation: Corrective actions address the root cause of an existing deviation to prevent
recurrence.
**Question 5. During a Management Review, which metric is least likely to be examined?**
A) Number of customer complaints
B) Equipment calibration status
C. Employee vacation schedules
D) Effectiveness of CAPA implementation
Answer: C
Explanation: Management Reviews focus on quality performance indicators, not personal
scheduling details.
**Question 6. In risk management, what does FMEA stand for?**
A) Failure Mode Effect Assessment
B) Fault Management Evaluation Analysis
C) Failure Mode and Effects Analysis
D) Functional Monitoring and Evaluation Audit
, [GMP] GMP GOOD MANUFACTURING
PRACTICES Certification Review Guide
Answer: C
Explanation: FMEA is a systematic tool to identify potential failure modes, their causes, and
effects, helping prioritize risk mitigation.
**Question 7. Which role is primarily responsible for ensuring that GMP training programs are
delivered and documented?**
A) Production Supervisor
B) Quality Assurance Manager
C) Human Resources Director
D) Facility Maintenance Engineer
Answer: B
Explanation: The QA Manager oversees training content, delivery, and records to ensure
compliance.
**Question 8. What is the minimum frequency for refresher GMP training for personnel directly
involved in sterile manufacturing?**
A) Every 5 years
B) Every 3 years
C) Annually
D) Every 2 years
Answer: C
Explanation: Annual refresher training is required to keep staff updated on aseptic techniques
and regulatory changes.
**Question 9. Which of the following health requirements is mandatory for employees working
in a cleanroom?**
A) Annual dental check‑up
, [GMP] GMP GOOD MANUFACTURING
PRACTICES Certification Review Guide
B) Vaccination against hepatitis B
C) Vision test every 2 years
D) Blood pressure monitoring weekly
Answer: B
Explanation: Hepatitis B vaccination protects both the employee and product from potential
contamination.
**Question 10. In a controlled environment, which personal item is strictly prohibited to
minimize contamination risk?**
A) Safety glasses
B) Disposable hair cap
C) Stainless‑steel watch
D) Laboratory coat
Answer: C
Explanation: Metal watches can shed particles and are prohibited; disposable or cleanable PPE
is allowed.
**Question 11. Which grade of cleanroom typically requires full-body, breathable,
low‑particulate gowns?**
A) ISO Class 9
B) ISO Class 7
C) ISO Class 5
D) ISO Class 3
Answer: C
Explanation: ISO Class 5 (or higher) environments used for sterile manufacturing demand full-
body, low‑particulate gowns.
PRACTICES Certification Review Guide
**Question 1. Which element of a Quality Management System (QMS) defines the
organization’s commitment to product safety and efficacy?**
A) Standard Operating Procedures (SOPs)
B) Quality Policy
C) Batch Production Record (BPR)
D) Calibration schedule
Answer: B
Explanation: The Quality Policy is a formal statement that expresses top‑management’s
commitment to safety, efficacy, and compliance, forming the foundation of the QMS.
**Question 2. In the hierarchy of GMP documentation, which document provides the highest
level of detail for day‑to‑day operations?**
A) Quality Manual
B) SOP
C) Work Instruction
D) Record
Answer: C
Explanation: Work Instructions break down SOPs into step‑by‑step actions for operators,
offering the most detailed guidance.
**Question 3. What is the primary purpose of a Change Control procedure?**
A) To approve new product formulations only
B) To manage any modification to processes, equipment, or materials in a controlled manner
C) To document employee training records
D) To schedule routine equipment maintenance
Answer: B
, [GMP] GMP GOOD MANUFACTURING
PRACTICES Certification Review Guide
Explanation: Change Control ensures that any alteration is evaluated for impact on product
quality and compliance before implementation.
**Question 4. Which of the following best describes a corrective action in a CAPA system?**
A) Identifying a potential future risk
B) Eliminating the cause of a detected non‑conformance
C) Training staff on new procedures
D) Updating the quality manual
Answer: B
Explanation: Corrective actions address the root cause of an existing deviation to prevent
recurrence.
**Question 5. During a Management Review, which metric is least likely to be examined?**
A) Number of customer complaints
B) Equipment calibration status
C. Employee vacation schedules
D) Effectiveness of CAPA implementation
Answer: C
Explanation: Management Reviews focus on quality performance indicators, not personal
scheduling details.
**Question 6. In risk management, what does FMEA stand for?**
A) Failure Mode Effect Assessment
B) Fault Management Evaluation Analysis
C) Failure Mode and Effects Analysis
D) Functional Monitoring and Evaluation Audit
, [GMP] GMP GOOD MANUFACTURING
PRACTICES Certification Review Guide
Answer: C
Explanation: FMEA is a systematic tool to identify potential failure modes, their causes, and
effects, helping prioritize risk mitigation.
**Question 7. Which role is primarily responsible for ensuring that GMP training programs are
delivered and documented?**
A) Production Supervisor
B) Quality Assurance Manager
C) Human Resources Director
D) Facility Maintenance Engineer
Answer: B
Explanation: The QA Manager oversees training content, delivery, and records to ensure
compliance.
**Question 8. What is the minimum frequency for refresher GMP training for personnel directly
involved in sterile manufacturing?**
A) Every 5 years
B) Every 3 years
C) Annually
D) Every 2 years
Answer: C
Explanation: Annual refresher training is required to keep staff updated on aseptic techniques
and regulatory changes.
**Question 9. Which of the following health requirements is mandatory for employees working
in a cleanroom?**
A) Annual dental check‑up
, [GMP] GMP GOOD MANUFACTURING
PRACTICES Certification Review Guide
B) Vaccination against hepatitis B
C) Vision test every 2 years
D) Blood pressure monitoring weekly
Answer: B
Explanation: Hepatitis B vaccination protects both the employee and product from potential
contamination.
**Question 10. In a controlled environment, which personal item is strictly prohibited to
minimize contamination risk?**
A) Safety glasses
B) Disposable hair cap
C) Stainless‑steel watch
D) Laboratory coat
Answer: C
Explanation: Metal watches can shed particles and are prohibited; disposable or cleanable PPE
is allowed.
**Question 11. Which grade of cleanroom typically requires full-body, breathable,
low‑particulate gowns?**
A) ISO Class 9
B) ISO Class 7
C) ISO Class 5
D) ISO Class 3
Answer: C
Explanation: ISO Class 5 (or higher) environments used for sterile manufacturing demand full-
body, low‑particulate gowns.
