SQA SQA Auditing and Inspection 2 — Questions and Answers
Question 1: What is the purpose of a closing meeting at the end of a GxP audit?
- To present the audit findings to management, discuss their significance, and confirm factual accuracy before the formal audit report is issued (Correct answer)
- To allow the auditee to challenge and remove findings before the formal report is written
- To sign off on all CAPA commitments and timelines before the auditor leaves the facility
- To return all confidential documents and records reviewed during the audit activities
Correct 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.
Question 2: What distinguishes a 'for cause' audit from a routine audit in a pharmaceutical setting?
- 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 (Correct answer)
- A for-cause audit is always unannounced; a routine audit is always announced in advance
- A for-cause audit is conducted only by regulatory agencies; routine audits are internal only
- A for-cause audit focuses exclusively on laboratory systems; routine audits cover all GMP areas
Correct 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.
Question 3: What is an audit checklist and what role does it play in a GxP audit?
- A pre-prepared list of topics, questions, or criteria to be assessed during an audit, ensuring comprehensive and consistent coverage (Correct answer)
- A mandatory list of documents the auditee must prepare before the audit begins
- A list of all employees who must be available for interviews during the audit
- A scoring form the auditor uses to assign numerical ratings to each quality area
Correct 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.
Question 4: When an audit finds a critical GMP violation, what is the typical immediate response expected?
- Immediate containment action to stop or mitigate the risk, followed by a formal CAPA plan with root cause analysis and preventive measures (Correct answer)
- Stopping all manufacturing operations permanently until regulatory authorities approve a restart
- Filing an adverse event report with the FDA within 24 hours of finding the violation
- Issuing a voluntary product recall immediately as a precautionary measure
Correct 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.
Question 5: What is 'audit trail review' in the context of a computer system audit?
- Examination of electronic audit trail records to verify data integrity, identify unauthorized changes, and assess GxP compliance of data handling (Correct answer)
- A review of the technical configuration specifications of the audit trail system
- An assessment of how long audit trail data is retained in the system before purging
- A validation test confirming that the audit trail functionality is technically operational
Correct 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.
Question 6: What is the purpose of a mock inspection or pre-approval inspection readiness audit?
- To simulate an FDA inspection to identify and correct compliance gaps before the actual regulatory inspection occurs (Correct answer)
- To train new auditors by having them shadow and observe an experienced senior auditor
- To evaluate the overall performance and effectiveness of the internal audit team
- To audit a new contract manufacturer before formally approving them as a supplier
Correct 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.
SQA SQA Auditing and Inspection 2
What is the purpose of a closing meeting at the end of a GxP audit?