SQA SQA Auditing and Inspection

Question 1

What is the primary difference between an internal audit and an external audit in a GxP quality system?

Accepted Answer

Internal audits are conducted by the organization's own staff to evaluate their own systems; external audits are conducted by customers, regulators, or other outside parties

Answer

Internal audits (self-inspections) are performed by internal staff to assess compliance with procedures and regulations, while external audits are conducted by customers, suppliers, or regulatory agencies.

Question 2

What is a supplier audit in the context of a pharmaceutical quality system?

Accepted Answer

An audit of a vendor's facility and quality systems to verify they meet the manufacturer's quality and regulatory requirements

Answer

A supplier audit assesses whether a vendor's quality systems, practices, and facilities can reliably supply materials or services that meet the manufacturer's requirements.

Question 3

In a GxP audit, what is an 'audit finding'?

Accepted Answer

A documented observation of a deviation from established requirements, regulations, or standards identified during an audit

Answer

An audit finding documents a specific instance where evidence showed non-compliance with requirements, forming the basis for corrective action.

Question 4

What is a 'critical' audit finding in a pharmaceutical GMP audit?

Accepted Answer

A finding that poses immediate risk to patient safety, product quality, or data integrity requiring immediate corrective action

Answer

Critical findings represent the most severe category, involving conditions that could directly harm patients, lead to fraud, or significantly compromise product quality.

Question 5

What is the purpose of an audit opening meeting?

Accepted Answer

To introduce the audit team, explain the audit scope, objectives, and schedule, and establish communication protocols with the auditee

Answer

The opening meeting establishes the ground rules, defines scope and objectives, introduces auditors and hosts, and ensures the auditee understands the audit process.

SQA - Society of Quality Assurance Practice Test

SQA - Society of Quality Assurance Practice Test

SQA SQA Auditing and Inspection