KAPS Regulatory Affairs and Quality Assurance 2

Question 1

Which FDA guidance document outlines the process analytical technology (PAT) framework for pharmaceutical manufacturing?

Accepted Answer

FDA PAT Guidance 2004

Answer

The FDA issued its PAT guidance in 2004, titled 'PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance.'

Question 2

Under 21 CFR Part 314, what is the standard review period for a standard NDA after it is accepted for filing?

Accepted Answer

10 months

Answer

The standard FDA review goal for an NDA under PDUFA is 10 months from the date of filing.

Question 3

Which ICH guideline specifically addresses pharmaceutical development and the concept of design space?

Accepted Answer

ICH Q8(R2)

Answer

ICH Q8(R2) on Pharmaceutical Development introduced the concept of design space as the multidimensional combination of input variables that provides quality assurance.

Question 4

A pharmaceutical company receives an FDA Form 483 after a GMP inspection. What does this form represent?

Accepted Answer

Inspectional observations of conditions that may be objectionable

Answer

FDA Form 483 lists inspectional observations of conditions the investigator found that may constitute violations of GMP regulations, but it is not a final agency determination.

Question 5

What is the primary purpose of a Drug Master File (DMF) submitted to the FDA?

Accepted Answer

To provide confidential detailed information about facilities, processes, or articles used in manufacturing

Answer

A DMF allows manufacturers to provide confidential supporting information to the FDA without disclosing proprietary data directly to NDA/ANDA applicants.

(KAPS) Knowledge Assessment of Pharmaceutical Sciences Practice Test

(KAPS) Knowledge Assessment of Pharmaceutical Sciences Practice Test

KAPS Regulatory Affairs and Quality Assurance 2