SQA Quality Auditing Principles 1 — Questions and Answers
Question 1: What is the primary purpose of a GLP facility inspection conducted by the QAU?
- To verify that facilities, equipment, personnel, and methods comply with GLP regulations (Correct answer)
- To approve study protocols before initiation
- To assign study personnel to specific tasks
- To review statistical analysis plans
Correct answer: To verify that facilities, equipment, personnel, and methods comply with GLP regulations
Facility inspections verify ongoing GLP compliance across physical space, equipment, personnel qualifications, and procedures.
Question 2: Which type of QAU audit examines study activities at critical phases identified in the protocol?
- In-process study audit (Correct answer)
- Facility inspection
- Final report audit
- SOP audit
Correct answer: In-process study audit
In-process (or phase) study audits are conducted at critical phases to verify study conduct matches the approved protocol.
Question 3: According to GLP, the QAU must report its findings to which parties?
- Study Director and Test Facility Management (Correct answer)
- Sponsor only
- FDA only
- Study Director only
Correct answer: Study Director and Test Facility Management
GLP requires the QAU to report inspection findings to both the Study Director and Test Facility Management.
Question 4: What distinguishes a first-party audit from a second-party audit in quality assurance?
- A first-party audit is an internal self-assessment; a second-party audit is conducted by a customer or client (Correct answer)
- A first-party audit is conducted by the FDA; a second-party audit is conducted by a sponsor
- A first-party audit uses checklists; a second-party audit uses interviews only
- A first-party audit is unannounced; a second-party audit is announced
Correct answer: A first-party audit is an internal self-assessment; a second-party audit is conducted by a customer or client
First-party audits are internal audits performed by the organization on itself, while second-party audits are performed by an external interested party such as a customer.
Question 5: Which audit document formally conveys audit findings to facility management and requires a corrective action response?
- Audit report (Correct answer)
- Audit checklist
- Study protocol
- QAU statement
Correct answer: Audit report
The formal audit report communicates findings and nonconformances to management, who must respond with corrective actions.
Question 6: In quality auditing, what is a 'finding' classified as when it represents a departure from a GLP requirement?
- Nonconformance (Correct answer)
- Observation
- Recommendation
- Best practice deviation
Correct answer: Nonconformance
A nonconformance (or deficiency) is a finding where actual practice departs from a stated GLP requirement or SOP.
SQA Quality Auditing Principles 1
What is the primary purpose of a GLP facility inspection conducted by the QAU?