Trivia Quiz On Good Laboratory Practice Regulations

9 Questions | Total Attempts: 1290

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Trivia Quiz On Good Laboratory Practice Regulations

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Questions and Answers
  • 1. 
    Which of the following are GLP regulations or requirements?
    • A. 

      21CFR58

    • B. 

      40CFR160

    • C. 

      21CFR211

    • D. 

      A&C Only

    • E. 

      A&B Only

  • 2. 
    What are GLPs?
    • A. 

      Good Manufacturing Practices

    • B. 

      A Quality Assurance Sytem

    • C. 

      Great Listening Procedures

    • D. 

      A Quality Control Program

    • E. 

      All of the Above

  • 3. 
    What does Quality mean at PBL (regulated environment)?
    • A. 

      An objective definition that means meet requirements

    • B. 

      A subjective definition that means to meet or exceed expectations

    • C. 

      Both A and B

    • D. 

      Neither A nor B

  • 4. 
    Records are created:
    • A. 

      By Planning Documents (Protocols and SOPs)

    • B. 

      By DO'ing Documents

    • C. 

      By Checking Documents

    • D. 

      By Improvement Documents

    • E. 

      All of the above

  • 5. 
    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"
    • A. 

      Facility Management

    • B. 

      Study Director

    • C. 

      Quality Assurance Unit

    • D. 

      Quality Control Unit

    • E. 

      President

  • 6. 
    Study Director is a title from the regulation.  Select the correct answer about this regulatory title: 
    • A. 

      Ensures there are calibrated instruments available to perform the work.

    • B. 

      That the building has adequate ventilation

    • C. 

      Is the single point of contact for study control.

    • D. 

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

  • 7. 
    • A. 

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

    • B. 

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

    • C. 

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

    • D. 

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

    • E. 

      None of the above

  • 8. 
    What is NOT a test system?
    • A. 

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

    • B. 

      Reagents and Workspace around the experiment

    • C. 

      Items removed from an animal for further study by histopathology

  • 9. 
    The QAU
    • A. 

      Checks the work of the study director

    • B. 

      Approves the protocol in a GLP study