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
What is the primary regulatory purpose of the Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)?
Answer: To identify drug products approved on the basis of safety and effectiveness and to support generic substitution decisions
The Orange Book lists FDA-approved drug products and provides therapeutic equivalence ratings (e.g., AB) that pharmacists use to make generic substitution decisions.
Which validation type is performed to demonstrate that a manufacturing process consistently produces a product meeting its predetermined specifications without using prospective qualification data?
Answer: Retrospective validation
Retrospective validation uses accumulated historical batch production, testing, and control data to demonstrate that a process has been in a state of control.
Under 21 CFR Part 11, which of the following is a requirement for electronic records used in lieu of paper records?
Answer: Audit trails must capture the date, time, and author of any record creation or modification
21 CFR Part 11 requires computer-generated, time-stamped audit trails that independently record the date and time of operator entries and actions that create, modify, or delete electronic records.
What is the meaning of a 'critical quality attribute' (CQA) in pharmaceutical development?
Answer: Any physical, chemical, biological, or microbiological property that must be within an appropriate limit to ensure desired product quality
Per ICH Q8, a CQA is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.
Which FDA enforcement action is a seizure of goods conducted under 21 USC §334 typically used to address?
Answer: Removal of adulterated or misbranded products from commerce
Seizure under 21 USC §334 is a civil in rem action allowing the FDA to remove adulterated or misbranded products from distribution channels.
In a pharmaceutical quality system, what is the primary distinction between a 'deviation' and a 'change control'?
Answer: A deviation is an unplanned departure from an approved procedure, while change control manages planned modifications
A deviation is an unplanned, unintentional departure from approved procedures or specifications, whereas change control is a formal, pre-approved system to manage intentional modifications.
Which USP general chapter establishes the requirements for validation of compendial procedures?
Answer: USP
USP Validation of Compendial Procedures outlines the analytical performance characteristics (accuracy, precision, specificity, etc.) that should be evaluated during method validation.