PT716A_Day13_18601917108_QbD concept,elements

Pharmaceutical Quality by Design is discussed under which ICH guidelines?

• Q5

• Q8

• Q6

• Q3

the suitability of either a drug substance or drug product for its intended use and the product should meet its pre-specified quality attributes or regulatory specifications, is known as-

___________________ is a systemic, scientific, risk faced, holistic and proactive approach to pharmaceutical development that begin with predefined objectives and emphases product and process understanding and process control.

which of the following are key objectives of Qbd?

• to achieve meaningful product quality specification that are based on clinical performance.

• to increase process capability and reduce product variability and deflects by enhancing product and process design understanding and control.

• to increase product development and manufacturing efficiencies

• to enhance root cause analysis and post approval change management

what are the key elements of QbD?

• QTPP

• Product design and understanding following CMAs

• CQAs

• control strategy

• process capability and continual improvment

________________________ is a prospective summary of a quality characteristics of drug products.

what is the full form of CQAs?

____________ is the physical, chemical, biological or microbiological property of characteristics of an output material including finished drug product that should be within an appropriate limit, range or distribution to ensure the desired drug product

what are the typical quality attributes of a drug products?

• Assay

• content uniformity

• residual solvents

• microbial limits

product design and understanding of QbD is fall under which ICH guidelines?

• Q8(R2)

• Q7(R2)

• Q8(R1)

• Q8