SQA Quality Auditing Principles

Question 1

What is the primary purpose of a GLP facility inspection conducted by the QAU?

Accepted Answer

To verify that facilities, equipment, personnel, and methods comply with GLP regulations

Answer

To approve study protocols before initiation

Answer

To assign study personnel to specific tasks

Answer

To review statistical analysis plans

Question 2

Which type of QAU audit examines study activities at critical phases identified in the protocol?

Accepted Answer

In-process study audit

Answer

Facility inspection

Answer

Final report audit

Answer

SOP audit

Question 3

According to GLP, the QAU must report its findings to which parties?

Accepted Answer

Study Director and Test Facility Management

Answer

Sponsor only

Answer

FDA only

Answer

Study Director only

Question 4

What distinguishes a first-party audit from a second-party audit in quality assurance?

Accepted Answer

A first-party audit is an internal self-assessment; a second-party audit is conducted by a customer or client

Answer

A first-party audit is conducted by the FDA; a second-party audit is conducted by a sponsor

Answer

A first-party audit uses checklists; a second-party audit uses interviews only

Answer

A first-party audit is unannounced; a second-party audit is announced

Question 5

Which audit document formally conveys audit findings to facility management and requires a corrective action response?

Accepted Answer

Audit report

Answer

Audit checklist

Answer

Study protocol

Answer

QAU statement

Question 6

In quality auditing, what is a 'finding' classified as when it represents a departure from a GLP requirement?

Accepted Answer

Nonconformance

Answer

Observation

Answer

Recommendation

Answer

Best practice deviation