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

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?

Accepted Answer

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

Answer

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?

Accepted Answer

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

Answer

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?

Accepted Answer

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

Answer

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?

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

Answer

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

SQA - Society of Quality Assurance Practice Test

SQA - Society of Quality Assurance Practice Test

SQA SQA Auditing and Inspection 3