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

Facility inspections verify ongoing GLP compliance across physical space, equipment, personnel qualifications, and procedures.

Question 2

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

Accepted Answer

In-process study audit

Answer

In-process (or phase) study audits are conducted at critical phases to verify study conduct matches the approved protocol.

Question 3

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

Accepted Answer

Study Director and Test Facility Management

Answer

GLP requires the QAU to report inspection findings to both the Study Director and Test Facility Management.

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

First-party audits are internal audits performed by the organization on itself, while second-party audits are performed by an external interested party such as a customer.

Question 5

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

Accepted Answer

Audit report

Answer

The formal audit report communicates findings and nonconformances to management, who must respond with corrective actions.

SQA - Society of Quality Assurance Practice Test

SQA - Society of Quality Assurance Practice Test

SQA Quality Auditing Principles