SQA SQA Auditing and Inspection 1 — Questions and Answers
Question 1: What is the primary difference between an internal audit and an external audit in a GxP quality system?
- 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 (Correct answer)
- Internal audits cover manufacturing operations only; external audits cover quality systems only
- Internal audits are always unannounced; external audits are always scheduled in advance
- Internal audits always result in CAPA; external audits always result in regulatory action
Correct 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.
Question 2: What is a supplier audit in the context of a pharmaceutical quality system?
- An audit of a vendor's facility and quality systems to verify they meet the manufacturer's quality and regulatory requirements (Correct answer)
- A financial review of a supplier's invoicing and pricing structure
- An audit of incoming material test results provided on a supplier's certificate of analysis
- A review of a supplier's on-time delivery and fulfillment performance metrics
Correct 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.
Question 3: In a GxP audit, what is an 'audit finding'?
- A documented observation of a deviation from established requirements, regulations, or standards identified during an audit (Correct answer)
- Any observation made during an audit, whether compliant or non-compliant
- A positive acknowledgment of a particularly strong quality practice observed
- A formal report submitted to regulatory agencies after completing an internal audit
Correct 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.
Question 4: What is a 'critical' audit finding in a pharmaceutical GMP audit?
- A finding that poses immediate risk to patient safety, product quality, or data integrity requiring immediate corrective action (Correct answer)
- A finding involving a minor deviation from a non-critical administrative procedure
- A finding that affects only documentation systems but not actual manufacturing operations
- A finding that was already corrected by site staff before the audit report was issued
Correct 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.
Question 5: What is the purpose of an audit opening meeting?
- To introduce the audit team, explain the audit scope, objectives, and schedule, and establish communication protocols with the auditee (Correct answer)
- To review all previous audit reports and findings before beginning the current audit
- To conduct a walk-through of the facility before any detailed auditing begins
- To finalize the audit checklist with input and agreement from the auditee management
Correct 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.
Question 6: In SQA auditing, what does 'objective evidence' mean?
- Verifiable information such as records, statements of fact, or observations that support audit findings, free from subjectivity (Correct answer)
- Personal opinions of highly experienced auditors about the quality of a system
- Statistical trend data showing process performance over a defined time period
- Any document that was reviewed by the auditor during the audit activities
Correct 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.
SQA SQA Auditing and Inspection 1
What is the primary difference between an internal audit and an external audit in a GxP quality system?