SQA Auditing and Inspection Flashcards

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

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

The closing meeting presents all audit findings to site management, allows clarification of factual accuracy, and sets expectations for the formal audit report and response timelines.

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

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

For-cause audits are reactive, triggered by specific incidents like product failures or regulatory concerns, while routine audits are proactive and scheduled.

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

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

An audit checklist guides auditors through key areas ensuring systematic, consistent coverage of applicable requirements, though skilled auditors adapt it based on live observations.

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

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

Critical findings require prompt containment (e.g., quarantining affected product, halting the process) followed by a systematic CAPA addressing root cause and prevention.

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

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

Audit trail review involves examining the electronic record of all data changes and system events to detect anomalies, data integrity issues, or unauthorized modifications.

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

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

A mock inspection mimics an FDA or notified body inspection, identifying compliance vulnerabilities so the company can address them before the real regulatory inspection.