QbD full form

• Quality by Design

• Quantity by Design

Key elements of QbD

• QTTP

• CQA

• Design Space

• All the above

Which ICH guideline focus on Quality Risk Management

• ICH Q8

• ICH Q9

• ICH Q10

• ICH Q7

Which strategy SAVE TIME to get QUALITY PRODUCT

• OFAT

• DOE

How is a low level variable coded?

• +1

• 0

• -1

What is the quantitative casual diagram used to identify possible failures in a system/process

• Quantitative diagram

• Fish bone diagram

• Tree root diagram

Operating space is a subset of design space

• True

• False

Which of the following is the correct ORDER

• Design Space --) CQA---) Risk Assessment ----)DoE ---) QTTP

• DoE ---) ----) Design Space ---) QTTP --) CQA---) Risk Assessment

• QTTP --) CQA---) Risk Assessment ----)DoE ---) Design Space

DoE is one of the tools of QbD

• True

• False

When to use Response Surface Methodology [RSM]?

• P < 0.05 for curvature

• P >0.05 for curvature

• P=0.05 for curvature