SQA SQA Regulatory Compliance and GxP 3

Question 1

What is the significance of ICH Q10 guidelines for pharmaceutical quality systems?

Accepted Answer

It provides a model for an effective pharmaceutical quality system throughout the product lifecycle

Answer

It defines analytical method validation criteria

Answer

It sets raw material testing requirements only

Answer

It establishes clinical trial data standards

Question 2

What is the purpose of incoming material qualification in a GxP environment?

Accepted Answer

To verify that raw materials from suppliers meet defined specifications before use in manufacturing

Answer

To approve new equipment for the production floor

Answer

To certify new employees for GMP manufacturing roles

Answer

To qualify analytical instruments before calibration

Question 3

What is a consent decree issued by the FDA?

Accepted Answer

A court-ordered agreement setting specific requirements a company must fulfill to continue regulated operations

Answer

An approval letter for new product lines after an inspection

Answer

A list of approved suppliers for a regulated manufacturer

Answer

A schedule for routine future regulatory inspections

Question 4

In regulated US laboratories, what is the primary function of a Laboratory Information Management System (LIMS)?

Accepted Answer

To manage, track, and store laboratory data, samples, and workflows in compliance with GxP requirements

Answer

To automatically order laboratory supplies when stock is low

Answer

To calculate employee productivity and workload metrics

Answer

To generate regulatory submission documents automatically

Question 5

What is the primary goal of a supplier qualification program in a GxP-regulated US company?

Accepted Answer

To ensure that vendors meet quality and regulatory standards before supplying materials or services

Answer

To negotiate better pricing and terms from approved vendors

Answer

To reduce the number of approved suppliers to a manageable list

Answer

To audit internal manufacturing departments on supplier-related issues

Question 6

Which US regulation applies Good Manufacturing Practices specifically to medical device manufacturers?

Accepted Answer

21 CFR Part 820 (Quality System Regulation)

Answer

21 CFR Part 211

Answer

21 CFR Part 58

Answer

21 CFR Part 312