SQA MCQ 2

Question 1

Under FDA 21 CFR Part 58, which individual is ultimately responsible for ensuring a GLP study is conducted in compliance with regulations?

Accepted Answer

Testing facility management

Answer

Testing facility management bears ultimate responsibility for GLP compliance, including providing qualified personnel and resources.

Question 2

An SOP is found to have been used in its draft form for six months without final approval. Which CAPA element is MOST critical to address first?

Accepted Answer

Root cause analysis of why the SOP was not approved

Answer

Root cause analysis must be completed first to understand the systemic failure before corrective and preventive actions can be properly designed.

Question 3

In GCP trials, what is the primary purpose of the Investigator's Brochure (IB)?

Accepted Answer

To provide investigators with clinical and nonclinical data about the investigational product

Answer

The IB compiles relevant clinical and nonclinical data to enable investigators to understand the rationale for and comply with the protocol.

Question 4

Which ICH guideline specifically addresses the stability testing of new drug substances and products?

Accepted Answer

ICH Q1A(R2)

Answer

ICH Q1A(R2) provides guidance on stability testing of new drug substances and drug products, including storage conditions and testing intervals.

Question 5

A QA auditor discovers that chromatography data was reprocessed without documented justification. This is BEST classified as:

Accepted Answer

A data integrity violation

Answer

Undocumented reprocessing of raw data constitutes a data integrity violation, which is a serious GxP compliance issue.

SQA - Society of Quality Assurance Practice Test