SQA Auditing and Inspection Flashcards

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

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

Effectiveness verification is the critical step confirming through objective evidence that actions taken eliminated the root cause and prevented recurrence of the problem.

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

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

An audit program is a risk-based schedule of audits ensuring all relevant GxP areas, processes, and suppliers are audited at appropriate frequencies over time.

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

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

Right-of-audit provisions in contracts grant the sponsoring company authority to audit CMOs or suppliers, reflecting the principle that quality oversight extends through the supply chain.

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

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

Repeat findings demonstrate that previous CAPAs failed to resolve the root cause or prevent recurrence, indicating a deeper systemic failure requiring escalated management attention.

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

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

Risk-based audit programs allocate more frequent auditing resources to areas with greater impact on product quality or patient safety, optimizing oversight efficiency.

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

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

A remote audit reviews quality records, procedures, and data submitted electronically, enabling some level of quality oversight without requiring an on-site visit.