What Do You Know About Chemical Module? Trivia Quiz

10 Questions | Total Attempts: 17

SettingsSettingsSettings
Please wait...
What Do You Know About Chemical Module? Trivia Quiz

.


Questions and Answers
  • 1. 
    To speed up an NPI project, there are no issues launching with only a 12 month shelf life.
    • A. 

      True

    • B. 

      False

  • 2. 
    Product should be in its primary package to conduct stabilities used to justify commercial shelf life.
    • A. 

      True

    • B. 

      False

  • 3. 
    How long do you need to test a room temperature product at 40C to justify 24 months of shelf life?
    • A. 

      6 months

    • B. 

      3 months

    • C. 

      12 months

    • D. 

      1 month

  • 4. 
    Physical methods (viscosity, appearance), don’t require method validation
    • A. 

      True

    • B. 

      False

  • 5. 
    Method validation usually consists of demonstrating precision (an analyst can get similar results with multiple tests), accuracy (multiple analysts can get similar results), and non-interference of excipients.
    • A. 

      True

    • B. 

      False

  • 6. 
    A Process Validation (PV) is typically conducted by verifying 1 batch meets specification at the top, middle and bottom of the batch
    • A. 

      True

    • B. 

      False

  • 7. 
    How do you find a COA specification in Agile?
    • A. 

      Using the chemical PN

    • B. 

      Using the product code

    • C. 

      Using the finished good cover page

    • D. 

      COA specifications are not in Agile

  • 8. 
    Micro testing shouldn’t add any time to your overall schedule.
    • A. 

      True

    • B. 

      False

  • 9. 
    What is the difference between precision & accuracy
    • A. 

      Precision and Accuracy are not related

    • B. 

      Accuracy is how close repeated values are to each other & precision is how close reported values are to the true value

    • C. 

      Precision is how close repeated values are to each other & accuracy is how close reported values are to the true value

    • D. 

      Option 4