Product Development & Compliance Flashcards
7 cards from real CRAP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Product Development & Compliance flashcards as text
During the Design Control process under 21 CFR Part 820, which document formally captures the intended use and user needs before design specifications are written?
Answer: Design Input requirements
Design Input requirements translate user needs and intended use into specific technical requirements before the design process begins.
A sponsor conducting a first-in-human clinical trial for a medical device in the US must submit which document to FDA before proceeding?
Answer: Investigational Device Exemption (IDE)
An IDE allows a medical device to be used in a clinical study to collect safety and effectiveness data without requiring full premarket approval.
Under ICH Q8(R2), which development approach encourages defining a Design Space based on the relationship between process parameters and product quality attributes?
Answer: Quality by Design (QbD)
Quality by Design systematically designs pharmaceutical development to meet predefined objectives, including defining a Design Space that assures quality.
Which risk management standard is most commonly applied during medical device product development to identify and control device-related hazards?
Answer: ISO 14971
ISO 14971 provides a framework for manufacturers to identify hazards, estimate risks, evaluate risks, control risks, and monitor the effectiveness of controls.
A pharmaceutical company discovers a Critical Quality Attribute (CQA) is impacted by raw material variability. Per ICH Q9, what is the most appropriate next action?
Answer: Perform a formal risk assessment to determine control strategy adjustments
ICH Q9 directs manufacturers to conduct formal risk assessments when quality risks are identified, then adjust the control strategy proportionally to the risk level.
In the context of combination products in the US, what determines the regulatory pathway (drug, device, or biologic) for a combination product?
Answer: The primary mode of action (PMOA)
FDA assigns a combination product to an agency center based on the primary mode of action of the combination product as a whole.
Which phase of the Stage-Gate development process is specifically focused on verifying that manufacturing processes can consistently produce product meeting specifications?
Answer: Process validation
Process validation provides documented evidence that a manufacturing process consistently produces a product meeting its predetermined specifications and quality attributes.