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 cover manufacturing operations only; external audits cover quality systems only

Answer

Internal audits are always unannounced; external audits are always scheduled in advance

Answer

Internal audits always result in CAPA; external audits always result in regulatory action

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 financial review of a supplier's invoicing and pricing structure

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An audit of incoming material test results provided on a supplier's certificate of analysis

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A review of a supplier's on-time delivery and fulfillment performance metrics

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

Any observation made during an audit, whether compliant or non-compliant

Answer

A positive acknowledgment of a particularly strong quality practice observed

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A formal report submitted to regulatory agencies after completing an internal audit

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

A finding involving a minor deviation from a non-critical administrative procedure

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A finding that affects only documentation systems but not actual manufacturing operations

Answer

A finding that was already corrected by site staff before the audit report was issued

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

To review all previous audit reports and findings before beginning the current audit

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To conduct a walk-through of the facility before any detailed auditing begins

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To finalize the audit checklist with input and agreement from the auditee management

Question 6

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

Accepted Answer

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

Answer

Personal opinions of highly experienced auditors about the quality of a system

Answer

Statistical trend data showing process performance over a defined time period

Answer

Any document that was reviewed by the auditor during the audit activities