Continuous Improvement & Updates 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 Continuous Improvement & Updates flashcards as text
A regulatory affairs manager wants to benchmark submission timelines against industry standards. Which publicly available FDA database provides approval timeline data to support this analysis?
Answer: Drugs@FDA database and PDUFA performance reports
Drugs@FDA and PDUFA performance reports contain approval dates, review times, and cycle information that can be used to benchmark an organization's submission performance.
A pharmaceutical company implements a new electronic quality management system (eQMS). Which validation requirement applies under 21 CFR Part 11?
Answer: The system must be validated to ensure accuracy, reliability, and consistent performance
21 CFR Part 11 requires that electronic records systems be validated to ensure they accurately and reliably perform their intended functions.
An EU-regulated medical device company updates its Quality Management System to comply with MDR 2017/745 (replacing MDD). What is the PRIMARY change management priority?
Answer: Conduct a gap analysis between MDD requirements and MDR, then develop a remediation plan
A systematic gap analysis between existing MDD compliance and new MDR requirements is the essential first step to understanding what changes are needed and prioritizing remediation efforts.
Under 21 CFR 314.81, an annual report for an approved NDA must include trending data on what quality parameter?
Answer: Batch analyses and any out-of-specification results from the reporting period
NDA annual reports must include summaries of batch analyses and quality-related data, including any OOS results, to support the continued evaluation of product quality.
A company's internal audit identifies that change control records frequently lack adequate impact assessments. The MOST effective sustainable corrective action is to:
Answer: Revise the change control SOP and template to include mandatory structured impact assessment fields with examples
Embedding structured impact assessment requirements directly into the SOP and record template creates systemic improvement rather than relying on individual oversight.
A drug company's Quality Management Review reveals that the ratio of preventive actions to corrective actions is very low (10:90). What does this indicate about the company's quality culture?
Answer: The company is largely reactive rather than proactive in its quality management approach
A high corrective-to-preventive action ratio indicates the organization primarily responds to failures after they occur rather than identifying and eliminating potential risks proactively.
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.