SQA Auditing and Inspection Flashcards

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

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

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.

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

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

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.

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

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

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

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

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

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

What is the purpose of an audit opening meeting?

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

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

In SQA auditing, what does 'objective evidence' mean?

Answer: Verifiable information such as records, statements of fact, or observations that support audit findings, free from subjectivity

Objective evidence is factual information (records, test results, observable conditions) that can be verified and supports audit conclusions without relying on opinion or assumption.