Regulatory Affairs and Quality Assurance Flashcards
7 cards from real KAPS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Affairs and Quality Assurance flashcards as text
Which FDA guidance document outlines the process analytical technology (PAT) framework for pharmaceutical manufacturing?
Answer: FDA PAT Guidance 2004
The FDA issued its PAT guidance in 2004, titled 'PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance.'
Under 21 CFR Part 314, what is the standard review period for a standard NDA after it is accepted for filing?
Answer: 10 months
The standard FDA review goal for an NDA under PDUFA is 10 months from the date of filing.
Which ICH guideline specifically addresses pharmaceutical development and the concept of design space?
Answer: ICH Q8(R2)
ICH Q8(R2) on Pharmaceutical Development introduced the concept of design space as the multidimensional combination of input variables that provides quality assurance.
A pharmaceutical company receives an FDA Form 483 after a GMP inspection. What does this form represent?
Answer: Inspectional observations of conditions that may be objectionable
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.
What is the primary purpose of a Drug Master File (DMF) submitted to the FDA?
Answer: To provide confidential detailed information about facilities, processes, or articles used in manufacturing
A DMF allows manufacturers to provide confidential supporting information to the FDA without disclosing proprietary data directly to NDA/ANDA applicants.
Which regulation requires pharmaceutical manufacturers to investigate any unexplained discrepancy in batch production records, including yield failures?
Answer: 21 CFR 211.192
21 CFR 211.192 requires a thorough investigation of any unexplained discrepancy or failure of a batch to meet specifications, including yield.
In the context of pharmaceutical quality systems, what does CAPA stand for?
Answer: Corrective and Preventive Action
CAPA (Corrective and Preventive Action) is a quality system element used to identify, investigate, and eliminate the causes of actual or potential nonconformances.