Mixed Deck — All CRAP Topics Flashcards

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 company discovers a post-market safety issue requiring a recall. Under 21 CFR Part 7, what is the highest level of recall classification?

Answer: Class I

Class I recall is the most serious, indicating a reasonable probability that use of or exposure to a violative product will cause serious adverse health consequences or death.

Under 18 USC § 1001, making a materially false statement to FDA is a federal crime punishable by:

Answer: Up to 5 years imprisonment and fines

18 USC § 1001 makes materially false statements to any federal agency, including FDA, punishable by up to 5 years imprisonment plus fines.

How should risks be prioritized?

Answer: Based on probability of occurrence and potential impact

Prioritizing by probability and impact ensures resources are allocated to the risks most likely to cause significant harm, maximizing risk management effectiveness.

Under FDA regulations, which outcome qualifies an adverse event as 'serious'?

Answer: Death, life-threatening condition, hospitalization, disability, or congenital anomaly

A serious adverse event is defined as one resulting in death, life-threatening conditions, inpatient hospitalization, significant disability, congenital anomaly, or requiring medical intervention to prevent permanent harm.

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.

Under the EU GDPR, which principle requires that personal data collected in clinical trials be adequate, relevant, and limited to what is necessary?

Answer: Data minimization

The data minimization principle under GDPR Article 5(1)(c) requires that personal data be limited to what is necessary in relation to the purposes for which it is processed.

A company is conducting a benefit-risk analysis for a new drug submission. Which framework does FDA recommend for structured benefit-risk assessment?

Answer: FDA's Benefit-Risk Framework with five-factor analysis in Module 2.5

FDA's benefit-risk framework integrates analysis of disease severity, unmet need, benefits, risks, and risk management across the structured assessment in Module 2.5.

When a pharmaceutical company wishes to implement a continuous manufacturing process for a previously batch-manufactured product, FDA recommends addressing this change through:

Answer: A Prior Approval Supplement with comprehensive validation data supporting the continuous process

Moving from batch to continuous manufacturing is a major manufacturing change that requires a Prior Approval Supplement with data demonstrating the continuous process produces equivalent product quality.

When a Standard Operating Procedure (SOP) is retired, what is the best practice for handling the document?

Answer: Archive it with its superseded status clearly marked and retain per the document retention schedule

Retired SOPs must be archived rather than destroyed to support historical investigations and regulatory inspections.

Under CDSCO (India) regulations, what is the SUGAM portal used for?

Answer: Online submission of regulatory applications for drugs and devices

SUGAM is CDSCO's online portal for submitting and tracking regulatory applications for drugs, biologics, and medical devices in India.

Which behavior demonstrates professionalism?

Answer: Delivering accurate reports on time

Delivering accurate reports on time demonstrates professionalism by showcasing diligence, reliability, and respect for regulatory processes and deadlines. It reflects a commitment to quality work, attention to detail, and accountability, which are all critical attributes for success in regulatory affairs. This behavior ensures that regulatory bodies receive timely and trustworthy information for their evaluations.

In a QMS, document control procedures must ensure that:

Answer: Obsolete documents are removed from points of use and only current versions are available

Document control requires that obsolete documents be promptly removed or otherwise prevented from use to ensure only current, approved versions are utilized.

A Document Change Control procedure must include which of the following elements?

Answer: Impact assessment of the change on related documents and processes

Impact assessment ensures that changes to one document do not inadvertently invalidate or conflict with related documents or validated processes.

When FDA issues a 'final guidance' document, what is a regulated company's legal obligation to comply with it?

Answer: Compliance is voluntary, but the company must justify using a different approach

FDA guidance documents are not legally binding; companies may use alternative approaches but must demonstrate they meet the underlying regulatory standard.

In a risk matrix, a hazard with 'Critical' severity and 'Remote' probability would typically fall into which risk category?

Answer: Medium risk requiring risk reduction consideration

Critical severity combined with remote probability typically produces a medium risk level that warrants consideration of risk reduction measures.

Which of the following best describes the concept of 'professional accountability' in regulatory affairs?

Answer: Taking responsibility for one's decisions and their impact on public health and safety

Professional accountability means owning the consequences of one's regulatory decisions, especially those affecting public health and safety.

Under FDA regulations, what must appear on the principal display panel (PDP) of a drug product label?

Answer: Statement of identity and net quantity of contents

The PDP must include the statement of identity and net quantity of contents per FDA labeling requirements under 21 CFR Part 201.

Why is trend analysis valuable in monitoring?

Answer: It reveals patterns that predict future issues before they become critical

Trend analysis reveals patterns in system behavior that can predict future issues, enabling proactive intervention before problems impact users.

During post-market surveillance, newly identified field failures prompt a risk reassessment. Which step in ISO 14971 does this represent?

Answer: Production and post-production information review

ISO 14971 Clause 10 addresses production and post-production information, requiring manufacturers to review field data and update the risk management file accordingly.