Trivia Quiz On Good Laboratory Practice Regulations

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| By Thom Davis
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Thom Davis
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| Attempts: 12,789
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  • 1/10 Questions

    Records are created:

    • By Planning Documents (Protocols and SOPs)
    • By DO'ing Documents
    • By Checking Documents
    • By Improvement Documents
    • All of the above
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About This Quiz

Are you looking for multiple-choice questions on good laboratory practices? The quiz below contains a few questions about lab safety rules and regulations. Try them out and enhance your learning with us. A laboratory is not only home to delicate equipment but also to some chemicals which, if improperly handled, may lead to injuries. How well do you know laboratory regulations? Can you follow procedures correctly when it comes to experiments? This quiz will check how well you follow the regulations and your details regarding measures.

Trivia Quiz On Good Laboratory Practice Regulations - Quiz

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  • 2. 

    GLP, an official regulation was created by the FDA in which year?

    • 1976

    • 1977

    • 1978

    • 1979

    Correct Answer
    A. 1978
    Explanation
    GLP, which stands for Good Laboratory Practice, is an official regulation that was created by the FDA (Food and Drug Administration). The question asks for the year in which GLP was created, and the correct answer is 1978. This means that in 1978, the FDA established the GLP regulation to ensure the quality and integrity of non-clinical laboratory studies conducted for the submission of research data to support applications for research or marketing permits for FDA-regulated products.

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  • 3. 

    What are GLPs?

    • Good Manufacturing Practices

    • A Quality Assurance Sytem

    • Great Listening Procedures

    • A Quality Control Program

    • All of the Above

    Correct Answer
    A. A Quality Assurance Sytem
    Explanation
    GLPs stand for Good Laboratory Practices, which are a set of guidelines and regulations that ensure the quality and integrity of non-clinical laboratory studies. These practices include the proper documentation of procedures, personnel training, equipment calibration, and data management. GLPs are essential in maintaining accurate and reliable results in research and development, as well as in regulatory submissions for pharmaceuticals, chemicals, and other products. Therefore, GLPs can be considered a quality assurance system as they provide a framework for ensuring the quality and reliability of laboratory studies.

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  • 4. 

    What does Quality mean at PBL (regulated environment)?

    • An objective definition that means meet requirements

    • A subjective definition that means to meet or exceed expectations

    • Both A and B

    • Neither A nor B

    Correct Answer
    A. An objective definition that means meet requirements
    Explanation
    Quality at PBL in a regulated environment is defined objectively as meeting the specified requirements. This means that the products or services provided by PBL must adhere to the predetermined standards and criteria set by regulations. The subjective aspect of quality, which involves exceeding expectations, is not applicable in this context. Therefore, the correct answer is an objective definition that means meet requirements.

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  • 5. 

    Which of the following are GLP regulations or requirements?

    • 21CFR58

    • 40CFR160

    • 21CFR211

    • A&C Only

    • A&B Only

    Correct Answer
    A. A&B Only
    Explanation
    The correct answer is A&B Only. This is because 21CFR58 and 40CFR160 are both GLP regulations or requirements. 21CFR211, on the other hand, is not a GLP regulation or requirement.

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  • 6. 

    What distinguishes a test article from a control article?

    • Anything taken out of a test system is a control article.

    • A test article is subjected to the test system and is received from the customer.

    • A control article is water or food that is subjected to the test system.

    • A control article is used to compare results with the specimens.

    • None of the above

    Correct Answer
    A. A test article is subjected to the test system and is received from the customer.
    Explanation
    A test article is distinguished from a control article by the fact that it is subjected to the test system and is received from the customer. This means that the test article is specifically chosen and provided by the customer for testing purposes. In contrast, a control article is typically used as a standard or reference for comparison with the specimens being tested.

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  • 7. 

    Plan what you do, Do what you Plan, Check your work, Improve for your Customer is the Quality cycle. Who among the following is most responsible for "Planning"

    • Facility Management

    • Study Director

    • Quality Assurance Unit

    • Quality Control Unit

    • President

    Correct Answer
    A. Facility Management
    Explanation
    Facility Management is most responsible for "Planning" in the Quality cycle. Facility Management involves the coordination and planning of various aspects related to the physical infrastructure, equipment, and resources of an organization. In the context of the Quality cycle, Facility Management would be responsible for planning and organizing the necessary facilities and resources required to ensure the quality of products or services. This includes planning for maintenance, calibration, and availability of equipment, as well as ensuring a suitable working environment for the employees.

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  • 8. 

    What is NOT a test system?

    • Any animal, plant or microorganism (or subparts) to which the test article is administered.

    • Reagents and Workspace around the experiment

    • Items removed from an animal for further study by histopathology

    • All of the above

    Correct Answer
    A. Items removed from an animal for further study by histopathology
    Explanation
    The correct answer is "Items removed from an animal for further study by histopathology." This is because the question asks for something that is NOT a test system, and the other options listed (any animal, plant or microorganism, reagents and workspace around the experiment) can all be considered test systems in some way. However, items removed from an animal for further study by histopathology are not considered a test system themselves, but rather samples taken from a test system for analysis.

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  • 9. 

    The QAU

    • Checks the work of the study director

    • Approves the protocol in a GLP study

    • Checks the quantity of the work done

    • All A, B, and C options are correct.

    Correct Answer
    A. Checks the work of the study director
    Explanation
    The Quality Assurance Unit (QAU) is responsible for ensuring that all aspects of a study are conducted in accordance with Good Laboratory Practice (GLP) regulations. This includes checking the work of the study director to ensure that they are following the approved protocol and conducting the study properly. Therefore, the statement "Checks the work of the study director" is correct as it accurately describes one of the responsibilities of the QAU in a GLP study.

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  • 10. 

    Study Director is a title from the regulation. Select the correct answer about this regulatory title: 

    • Ensures there are calibrated instruments available to perform the work.

    • That the building has adequate ventilation

    • Is the single point of contact for study control.

    • Performs monitoring and inspection adequate to insure the integrity of the study.

    Correct Answer
    A. Is the single point of contact for study control.
    Explanation
    The correct answer is "Is the single point of contact for study control." This means that the Study Director is responsible for coordinating and overseeing all aspects of a study, serving as the main point of contact for communication and control. They are responsible for ensuring that the study is conducted according to regulations and guidelines, managing resources, and ensuring the integrity of the study. This role involves coordinating with various stakeholders, including sponsors, investigators, and regulatory authorities.

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  • Current Version
  • Aug 24, 2023
    Quiz Edited by
    ProProfs Editorial Team
  • Oct 12, 2009
    Quiz Created by
    Thom Davis
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