Quality Auditing Principles Flashcards

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

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

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

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

Answer: In-process study audit

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

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

Answer: Study Director and Test Facility Management

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

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

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

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.

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

Answer: Audit report

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

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

Answer: Nonconformance

A nonconformance (or deficiency) is a finding where actual practice departs from a stated GLP requirement or SOP.