Certified Good Laboratory Practice Professional (CGLPP) Practice Exam
1. What is the primary purpose of Good Laboratory Practices (GLP)?
A. To increase research funding
B. To ensure the quality and integrity of laboratory studies
C. To reduce research personnel costs
D. To accelerate product commercialization
Answer: B
Explanation: GLP is designed to ensure that laboratory studies are performed consistently,
reliably, and with integrity, making data acceptable to regulatory authorities.
2. Which regulatory agency in the United States is primarily responsible for enforcing GLP
in drug development?
A. Environmental Protection Agency (EPA)
B. Food and Drug Administration (FDA)
C. Occupational Safety and Health Administration (OSHA)
D. Centers for Disease Control and Prevention (CDC)
Answer: B
Explanation: The FDA enforces GLP standards for non-clinical studies in support of applications
for research or marketing permits.
3. Which of the following is a key principle of GLP?
A. Profit maximization
B. Transparency
C. Market expansion
D. Product diversification
Answer: B
Explanation: Transparency in processes and data is a cornerstone of GLP, ensuring
reproducibility and accountability in laboratory work.
4. What does OECD stand for in the context of GLP guidelines?
A. Organization for Economic Cooperation and Development
B. Organization for Environmental Compliance and Oversight
C. Office for Experimental Control and Data
D. Organization for Ethical Clinical Development
Answer: A
Explanation: OECD stands for the Organization for Economic Cooperation and Development,
which provides internationally recognized GLP principles.
5. Which aspect is not a focus of GLP?
A. Data integrity
B. Study reproducibility
C. Laboratory profitability
D. Quality assurance
,Answer: C
Explanation: GLP focuses on ensuring the reliability and reproducibility of data rather than on
financial profitability.
6. What does the term “accountability” mean in the context of GLP?
A. Blaming staff for errors
B. Clear assignment of responsibilities
C. Limiting documentation
D. Reducing laboratory inspections
Answer: B
Explanation: Accountability in GLP refers to the clear assignment of responsibilities and
ensuring that everyone involved can be held responsible for their actions.
7. Which agency provides GLP guidelines for environmental studies in the United States?
A. FDA
B. EPA
C. USDA
D. CDC
Answer: B
Explanation: The Environmental Protection Agency (EPA) provides guidelines for
environmental studies, ensuring data quality and reliability.
8. What is one of the main roles of Quality Assurance (QA) in GLP?
A. Increasing laboratory profit margins
B. Conducting internal audits and ensuring compliance
C. Managing laboratory marketing strategies
D. Training only the management staff
Answer: B
Explanation: QA in GLP is responsible for auditing laboratory procedures, verifying compliance,
and ensuring that all processes meet established standards.
9. Which of the following best describes the evolution of GLP?
A. It was developed solely for pharmaceutical studies.
B. It evolved from the need to standardize practices and ensure reproducibility in non-clinical
studies.
C. It was created to improve industrial production techniques.
D. It originated from clinical trial regulations only.
Answer: B
Explanation: GLP evolved to standardize laboratory practices, ensuring that non-clinical studies
produce reliable and reproducible data acceptable to regulators.
10. In GLP, what is the significance of data integrity?
A. It minimizes the need for equipment calibration.
B. It ensures that data is accurate, consistent, and reliable.
C. It eliminates the need for regulatory audits.
D. It focuses on reducing study costs.
,Answer: B
Explanation: Data integrity is critical in GLP as it confirms that the data is accurate, consistent,
and reliable, thereby ensuring study credibility.
11. Which document is essential to record any deviations from the study protocol in a GLP-
compliant study?
A. Financial report
B. Corrective and Preventive Action (CAPA) report
C. Marketing plan
D. Press release
Answer: B
Explanation: CAPA reports document any deviations, corrective actions, and preventive
measures, which is essential for maintaining GLP compliance.
12. How often should laboratory equipment be calibrated in a GLP environment?
A. Once every five years
B. According to a predefined schedule based on manufacturer recommendations and study
requirements
C. Only when it malfunctions
D. Calibration is not necessary under GLP
Answer: B
Explanation: Equipment calibration must follow a schedule that considers manufacturer
recommendations and the specific needs of each study to maintain accuracy.
13. What is the role of study protocols in GLP studies?
A. They serve as marketing documents.
B. They define the study’s objectives, methodologies, and procedures ensuring consistency.
C. They are used only for financial audits.
D. They replace the need for data collection.
Answer: B
Explanation: Study protocols are comprehensive documents outlining study objectives,
methodologies, and procedures, ensuring that the study is conducted consistently and reliably.
14. Which regulatory body’s guidelines are most often used internationally to benchmark
GLP standards?
A. FDA
B. EPA
C. OECD
D. WHO
Answer: C
Explanation: The OECD guidelines are widely recognized internationally as the benchmark for
GLP standards, providing harmonized principles.
15. What does GLP emphasize regarding laboratory personnel?
A. Their ability to increase production
B. Their training, qualifications, and adherence to ethical standards
, C. Their capacity to work independently without supervision
D. Their roles in financial management
Answer: B
Explanation: GLP emphasizes the importance of properly trained and qualified personnel who
adhere to ethical standards to ensure study integrity.
16. Which of the following is not typically maintained under GLP documentation?
A. Raw data
B. Final study reports
C. Personal opinions of the staff
D. Study protocols
Answer: C
Explanation: Personal opinions are not part of GLP documentation; only scientifically relevant
and validated data is recorded.
17. Why is transparency a key aspect of GLP?
A. It facilitates faster publication of research
B. It ensures that study methods and data are openly available for audit and review
C. It reduces the cost of laboratory operations
D. It improves employee satisfaction
Answer: B
Explanation: Transparency ensures that all aspects of the study are documented and available for
audit, which builds trust in the data and processes.
18. What is the importance of regular internal audits in a GLP-compliant laboratory?
A. To reduce staffing needs
B. To identify and correct non-compliances and ensure adherence to protocols
C. To boost sales performance
D. To eliminate the need for external reviews
Answer: B
Explanation: Internal audits help identify gaps in compliance, enabling the implementation of
corrective measures to maintain GLP standards.
19. What aspect does GLP documentation emphasize to ensure data credibility?
A. Timely marketing reports
B. Detailed record keeping and traceability
C. Minimal documentation for speed
D. Informal note-taking
Answer: B
Explanation: Detailed record keeping and traceability are crucial to ensuring that data can be
verified and audited, which is fundamental in GLP.
20. Which guideline organization specifically focuses on GLP for pharmaceutical studies in
Europe?
A. EMA
B. OSHA
1. What is the primary purpose of Good Laboratory Practices (GLP)?
A. To increase research funding
B. To ensure the quality and integrity of laboratory studies
C. To reduce research personnel costs
D. To accelerate product commercialization
Answer: B
Explanation: GLP is designed to ensure that laboratory studies are performed consistently,
reliably, and with integrity, making data acceptable to regulatory authorities.
2. Which regulatory agency in the United States is primarily responsible for enforcing GLP
in drug development?
A. Environmental Protection Agency (EPA)
B. Food and Drug Administration (FDA)
C. Occupational Safety and Health Administration (OSHA)
D. Centers for Disease Control and Prevention (CDC)
Answer: B
Explanation: The FDA enforces GLP standards for non-clinical studies in support of applications
for research or marketing permits.
3. Which of the following is a key principle of GLP?
A. Profit maximization
B. Transparency
C. Market expansion
D. Product diversification
Answer: B
Explanation: Transparency in processes and data is a cornerstone of GLP, ensuring
reproducibility and accountability in laboratory work.
4. What does OECD stand for in the context of GLP guidelines?
A. Organization for Economic Cooperation and Development
B. Organization for Environmental Compliance and Oversight
C. Office for Experimental Control and Data
D. Organization for Ethical Clinical Development
Answer: A
Explanation: OECD stands for the Organization for Economic Cooperation and Development,
which provides internationally recognized GLP principles.
5. Which aspect is not a focus of GLP?
A. Data integrity
B. Study reproducibility
C. Laboratory profitability
D. Quality assurance
,Answer: C
Explanation: GLP focuses on ensuring the reliability and reproducibility of data rather than on
financial profitability.
6. What does the term “accountability” mean in the context of GLP?
A. Blaming staff for errors
B. Clear assignment of responsibilities
C. Limiting documentation
D. Reducing laboratory inspections
Answer: B
Explanation: Accountability in GLP refers to the clear assignment of responsibilities and
ensuring that everyone involved can be held responsible for their actions.
7. Which agency provides GLP guidelines for environmental studies in the United States?
A. FDA
B. EPA
C. USDA
D. CDC
Answer: B
Explanation: The Environmental Protection Agency (EPA) provides guidelines for
environmental studies, ensuring data quality and reliability.
8. What is one of the main roles of Quality Assurance (QA) in GLP?
A. Increasing laboratory profit margins
B. Conducting internal audits and ensuring compliance
C. Managing laboratory marketing strategies
D. Training only the management staff
Answer: B
Explanation: QA in GLP is responsible for auditing laboratory procedures, verifying compliance,
and ensuring that all processes meet established standards.
9. Which of the following best describes the evolution of GLP?
A. It was developed solely for pharmaceutical studies.
B. It evolved from the need to standardize practices and ensure reproducibility in non-clinical
studies.
C. It was created to improve industrial production techniques.
D. It originated from clinical trial regulations only.
Answer: B
Explanation: GLP evolved to standardize laboratory practices, ensuring that non-clinical studies
produce reliable and reproducible data acceptable to regulators.
10. In GLP, what is the significance of data integrity?
A. It minimizes the need for equipment calibration.
B. It ensures that data is accurate, consistent, and reliable.
C. It eliminates the need for regulatory audits.
D. It focuses on reducing study costs.
,Answer: B
Explanation: Data integrity is critical in GLP as it confirms that the data is accurate, consistent,
and reliable, thereby ensuring study credibility.
11. Which document is essential to record any deviations from the study protocol in a GLP-
compliant study?
A. Financial report
B. Corrective and Preventive Action (CAPA) report
C. Marketing plan
D. Press release
Answer: B
Explanation: CAPA reports document any deviations, corrective actions, and preventive
measures, which is essential for maintaining GLP compliance.
12. How often should laboratory equipment be calibrated in a GLP environment?
A. Once every five years
B. According to a predefined schedule based on manufacturer recommendations and study
requirements
C. Only when it malfunctions
D. Calibration is not necessary under GLP
Answer: B
Explanation: Equipment calibration must follow a schedule that considers manufacturer
recommendations and the specific needs of each study to maintain accuracy.
13. What is the role of study protocols in GLP studies?
A. They serve as marketing documents.
B. They define the study’s objectives, methodologies, and procedures ensuring consistency.
C. They are used only for financial audits.
D. They replace the need for data collection.
Answer: B
Explanation: Study protocols are comprehensive documents outlining study objectives,
methodologies, and procedures, ensuring that the study is conducted consistently and reliably.
14. Which regulatory body’s guidelines are most often used internationally to benchmark
GLP standards?
A. FDA
B. EPA
C. OECD
D. WHO
Answer: C
Explanation: The OECD guidelines are widely recognized internationally as the benchmark for
GLP standards, providing harmonized principles.
15. What does GLP emphasize regarding laboratory personnel?
A. Their ability to increase production
B. Their training, qualifications, and adherence to ethical standards
, C. Their capacity to work independently without supervision
D. Their roles in financial management
Answer: B
Explanation: GLP emphasizes the importance of properly trained and qualified personnel who
adhere to ethical standards to ensure study integrity.
16. Which of the following is not typically maintained under GLP documentation?
A. Raw data
B. Final study reports
C. Personal opinions of the staff
D. Study protocols
Answer: C
Explanation: Personal opinions are not part of GLP documentation; only scientifically relevant
and validated data is recorded.
17. Why is transparency a key aspect of GLP?
A. It facilitates faster publication of research
B. It ensures that study methods and data are openly available for audit and review
C. It reduces the cost of laboratory operations
D. It improves employee satisfaction
Answer: B
Explanation: Transparency ensures that all aspects of the study are documented and available for
audit, which builds trust in the data and processes.
18. What is the importance of regular internal audits in a GLP-compliant laboratory?
A. To reduce staffing needs
B. To identify and correct non-compliances and ensure adherence to protocols
C. To boost sales performance
D. To eliminate the need for external reviews
Answer: B
Explanation: Internal audits help identify gaps in compliance, enabling the implementation of
corrective measures to maintain GLP standards.
19. What aspect does GLP documentation emphasize to ensure data credibility?
A. Timely marketing reports
B. Detailed record keeping and traceability
C. Minimal documentation for speed
D. Informal note-taking
Answer: B
Explanation: Detailed record keeping and traceability are crucial to ensuring that data can be
verified and audited, which is fundamental in GLP.
20. Which guideline organization specifically focuses on GLP for pharmaceutical studies in
Europe?
A. EMA
B. OSHA
