SQA SQA Auditing and Inspection 3

Question 1

What is 'CAPA effectiveness verification' in the context of auditing?

Accepted Answer

Confirming through follow-up evidence that corrective and preventive actions actually resolved the root cause and prevented recurrence

Answer

Reviewing that CAPA paperwork was completed and signed within the required timeframe

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Verifying that all CAPA tasks were assigned to appropriate personnel with correct due dates

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Confirming that CAPA plans were reviewed and approved by management before implementation

Question 2

What is an 'audit program' in a pharmaceutical quality system?

Accepted Answer

A systematic, documented schedule of planned audits covering all GxP systems, processes, and suppliers over a defined period

Answer

A single comprehensive audit conducted to cover all GMP requirements at one time

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A software tool used to manage and track audit findings and associated CAPAs

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A formal training program for developing and certifying internal auditors

Question 3

What does 'right of audit' refer to in a contract manufacturing agreement?

Accepted Answer

A contractual clause granting the customer or sponsor the right to audit the contract manufacturer's quality systems

Answer

The regulatory authority's legal right to access any FDA-regulated facility for inspection

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The right of an internal employee to audit their own department's processes and procedures

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A mutual audit agreement allowing both parties to inspect each other's facilities

Question 4

What is the significance of 'repeat findings' in a GxP audit context?

Accepted Answer

Repeat findings indicate a systemic quality system failure and suggest previous corrective actions were ineffective

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Repeat findings are automatically classified as minor observations regardless of their nature

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Repeat findings are expected in large complex facilities and do not require escalation

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Repeat findings are only significant if they occur more than five times across consecutive audits

Question 5

What is the role of 'audit frequency' in a risk-based quality audit program?

Accepted Answer

Higher-risk systems, processes, and suppliers are audited more frequently than lower-risk ones to ensure greater oversight where quality impact is greatest

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All systems are audited at exactly the same frequency regardless of their risk classification

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Audit frequency is determined solely by regulatory requirements with no internal risk assessment

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Lower-risk systems require more frequent audits to maintain their current low-risk classification

Question 6

What is a 'remote audit' or 'desk audit' in pharmaceutical quality assurance?

Accepted Answer

An audit conducted by reviewing documents, records, and evidence submitted electronically without physically visiting the site

Answer

An audit limited to reviewing only quality system documentation without entering production or laboratory areas

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A preliminary audit step performed before scheduling a full comprehensive on-site audit

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An audit conducted by a regulatory agency using only publicly available information about the company