SQA SQA Auditing and Inspection 3 — Questions and Answers
Question 1: What is 'CAPA effectiveness verification' in the context of auditing?
- Confirming through follow-up evidence that corrective and preventive actions actually resolved the root cause and prevented recurrence (Correct answer)
- Reviewing that CAPA paperwork was completed and signed within the required timeframe
- Verifying that all CAPA tasks were assigned to appropriate personnel with correct due dates
- Confirming that CAPA plans were reviewed and approved by management before implementation
Correct 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.
Question 2: What is an 'audit program' in a pharmaceutical quality system?
- A systematic, documented schedule of planned audits covering all GxP systems, processes, and suppliers over a defined period (Correct answer)
- A single comprehensive audit conducted to cover all GMP requirements at one time
- A software tool used to manage and track audit findings and associated CAPAs
- A formal training program for developing and certifying internal auditors
Correct 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.
Question 3: What does 'right of audit' refer to in a contract manufacturing agreement?
- A contractual clause granting the customer or sponsor the right to audit the contract manufacturer's quality systems (Correct answer)
- The regulatory authority's legal right to access any FDA-regulated facility for inspection
- The right of an internal employee to audit their own department's processes and procedures
- A mutual audit agreement allowing both parties to inspect each other's facilities
Correct 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.
Question 4: What is the significance of 'repeat findings' in a GxP audit context?
- Repeat findings indicate a systemic quality system failure and suggest previous corrective actions were ineffective (Correct answer)
- Repeat findings are automatically classified as minor observations regardless of their nature
- Repeat findings are expected in large complex facilities and do not require escalation
- Repeat findings are only significant if they occur more than five times across consecutive audits
Correct 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.
Question 5: What is the role of 'audit frequency' in a risk-based quality audit program?
- Higher-risk systems, processes, and suppliers are audited more frequently than lower-risk ones to ensure greater oversight where quality impact is greatest (Correct answer)
- All systems are audited at exactly the same frequency regardless of their risk classification
- Audit frequency is determined solely by regulatory requirements with no internal risk assessment
- Lower-risk systems require more frequent audits to maintain their current low-risk classification
Correct 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.
Question 6: What is a 'remote audit' or 'desk audit' in pharmaceutical quality assurance?
- An audit conducted by reviewing documents, records, and evidence submitted electronically without physically visiting the site (Correct answer)
- An audit limited to reviewing only quality system documentation without entering production or laboratory areas
- A preliminary audit step performed before scheduling a full comprehensive on-site audit
- An audit conducted by a regulatory agency using only publicly available information about the company
Correct 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.
SQA SQA Auditing and Inspection 3
What is 'CAPA effectiveness verification' in the context of auditing?