SQA Regulatory Compliance and GxP Flashcards
6 cards from real SQA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 SQA Regulatory Compliance and GxP flashcards as text
What is the significance of ICH Q10 guidelines for pharmaceutical quality systems?
Answer: It provides a model for an effective pharmaceutical quality system throughout the product lifecycle
ICH Q10 describes a comprehensive model for a pharmaceutical quality system that facilitates innovation and continual improvement across the full product lifecycle.
What is the purpose of incoming material qualification in a GxP environment?
Answer: To verify that raw materials from suppliers meet defined specifications before use in manufacturing
Incoming material qualification ensures raw materials and components meet quality specifications before being released for use in manufacturing.
What is a consent decree issued by the FDA?
Answer: A court-ordered agreement setting specific requirements a company must fulfill to continue regulated operations
A consent decree is a court order that sets specific remediation requirements a company must fulfill, often including third-party oversight.
In regulated US laboratories, what is the primary function of a Laboratory Information Management System (LIMS)?
Answer: To manage, track, and store laboratory data, samples, and workflows in compliance with GxP requirements
A LIMS manages laboratory operations including sample tracking, test scheduling, data storage, and reporting in a GxP-compliant manner.
What is the primary goal of a supplier qualification program in a GxP-regulated US company?
Answer: To ensure that vendors meet quality and regulatory standards before supplying materials or services
A supplier qualification program evaluates and approves vendors to ensure they meet quality, regulatory, and technical requirements before being used.
Which US regulation applies Good Manufacturing Practices specifically to medical device manufacturers?
Answer: 21 CFR Part 820 (Quality System Regulation)
21 CFR Part 820, the Quality System Regulation, establishes cGMP requirements for medical device design, manufacture, packaging, and distribution.
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