SQA SQA Auditing and Inspection 2

Question 1

What is the purpose of a closing meeting at the end of a GxP audit?

Accepted Answer

To present the audit findings to management, discuss their significance, and confirm factual accuracy before the formal audit report is issued

Answer

To allow the auditee to challenge and remove findings before the formal report is written

Answer

To sign off on all CAPA commitments and timelines before the auditor leaves the facility

Answer

To return all confidential documents and records reviewed during the audit activities

Question 2

What distinguishes a 'for cause' audit from a routine audit in a pharmaceutical setting?

Accepted Answer

A for-cause audit is triggered by a specific event or concern such as a complaint or failure; routine audits are scheduled at regular planned intervals

Answer

A for-cause audit is always unannounced; a routine audit is always announced in advance

Answer

A for-cause audit is conducted only by regulatory agencies; routine audits are internal only

Answer

A for-cause audit focuses exclusively on laboratory systems; routine audits cover all GMP areas

Question 3

What is an audit checklist and what role does it play in a GxP audit?

Accepted Answer

A pre-prepared list of topics, questions, or criteria to be assessed during an audit, ensuring comprehensive and consistent coverage

Answer

A mandatory list of documents the auditee must prepare before the audit begins

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A list of all employees who must be available for interviews during the audit

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A scoring form the auditor uses to assign numerical ratings to each quality area

Question 4

When an audit finds a critical GMP violation, what is the typical immediate response expected?

Accepted Answer

Immediate containment action to stop or mitigate the risk, followed by a formal CAPA plan with root cause analysis and preventive measures

Answer

Stopping all manufacturing operations permanently until regulatory authorities approve a restart

Answer

Filing an adverse event report with the FDA within 24 hours of finding the violation

Answer

Issuing a voluntary product recall immediately as a precautionary measure

Question 5

What is 'audit trail review' in the context of a computer system audit?

Accepted Answer

Examination of electronic audit trail records to verify data integrity, identify unauthorized changes, and assess GxP compliance of data handling

Answer

A review of the technical configuration specifications of the audit trail system

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An assessment of how long audit trail data is retained in the system before purging

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A validation test confirming that the audit trail functionality is technically operational

Question 6

What is the purpose of a mock inspection or pre-approval inspection readiness audit?

Accepted Answer

To simulate an FDA inspection to identify and correct compliance gaps before the actual regulatory inspection occurs

Answer

To train new auditors by having them shadow and observe an experienced senior auditor

Answer

To evaluate the overall performance and effectiveness of the internal audit team

Answer

To audit a new contract manufacturer before formally approving them as a supplier