Quality Systems and GMP Flashcards
7 cards from real RAC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Quality Systems and GMP flashcards as text
Under 21 CFR Part 211, who bears ultimate responsibility for approving or rejecting drug products?
Answer: Quality control unit
21 CFR 211.22 assigns responsibility for approving or rejecting all drug products to the quality control unit, which must be independent of production.
Which concept does ICH Q9 Quality Risk Management introduce as a foundation for risk-based decision-making?
Answer: Risk assessment, risk control, and risk review
ICH Q9 establishes risk assessment, risk control, and risk review as the core elements of a structured quality risk management process.
A company discovers that a released product lot may be adulterated. What is the first regulatory obligation?
Answer: Assess whether a recall or market withdrawal is required
Upon discovering potential adulteration, the company must assess the situation and determine if a recall, market withdrawal, or other action is required under 21 CFR Part 7.
In GMP terms, what distinguishes a 'critical process parameter' (CPP) from a general process parameter?
Answer: Variation in a CPP directly impacts a critical quality attribute of the product
A CPP is one whose variability has a direct impact on a critical quality attribute (CQA), making it essential to monitor and control during manufacturing.
What is the primary regulatory concern addressed by 21 CFR Part 11?
Answer: Electronic records and electronic signatures
21 CFR Part 11 establishes criteria under which FDA considers electronic records and electronic signatures to be trustworthy and equivalent to paper records.
Which statement correctly describes the relationship between GMP and validation?
Answer: Validation provides documented evidence that GMP processes consistently produce acceptable results
Validation provides the documented scientific evidence that GMP processes, equipment, and systems consistently produce outcomes meeting predetermined specifications.
Under GMP regulations, what is required when a major change is made to a manufacturing process?
Answer: Revalidation or evaluation to confirm the change does not adversely affect product quality
Major process changes require revalidation or a documented evaluation to confirm that product quality and consistency are not adversely affected by the change.