SQA SQA Inspector Roles and Responsibilities 2 — Questions and Answers
Question 1: Which skill is most critical for a QA inspector when reviewing laboratory raw data for GLP compliance?
- Attention to detail and the ability to identify missing, altered, or inconsistent entries (Correct answer)
- Expertise in the scientific methodology of the study
- Ability to recalculate all statistical analyses
- Proficiency in the laboratory's instrument software
Correct answer: Attention to detail and the ability to identify missing, altered, or inconsistent entries
Meticulous attention to detail is the core skill for data integrity review, enabling detection of gaps, alterations, and inconsistencies.
Question 2: What is the purpose of the SQA-GLP Symposium held annually in the United States?
- To provide professional development, regulatory updates, and networking for GLP quality assurance professionals (Correct answer)
- To certify new GLP facilities for FDA approval
- To issue annual GLP compliance reports to regulatory agencies
- To train FDA inspectors on GLP audit techniques
Correct answer: To provide professional development, regulatory updates, and networking for GLP quality assurance professionals
The SQA Annual Symposium is the primary professional development event for GLP QA professionals in the US, covering regulatory updates and best practices.
Question 3: Under GLP, which statement correctly describes the relationship between the QAU and the Study Director?
- The QAU is independent of the Study Director and reports findings to management; the Study Director is responsible for study conduct (Correct answer)
- The QAU reports to the Study Director and follows their direction on what to inspect
- The Study Director and QAU jointly sign the final report as co-equal authors
- The QAU supervises the Study Director's activities throughout the study
Correct answer: The QAU is independent of the Study Director and reports findings to management; the Study Director is responsible for study conduct
GLP requires the QAU to be organizationally independent of study conduct while the Study Director retains full responsibility for the study.
Question 4: What continuing education requirement is associated with maintaining the RQAP-GLP credential offered by SQA?
- Accumulating a required number of professional development units (PDUs) during each recertification cycle (Correct answer)
- Passing an annual written examination
- Publishing at least one peer-reviewed article per year
- Completing a supervised audit at an FDA-inspected facility annually
Correct answer: Accumulating a required number of professional development units (PDUs) during each recertification cycle
RQAP-GLP holders must accumulate professional development units (PDUs) to demonstrate ongoing competency for credential renewal.
Question 5: Which document best prepares a QA inspector for conducting a study-phase audit?
- The study protocol, relevant SOPs, and any previously issued protocol amendments (Correct answer)
- The facility's master schedule only
- The previous year's FDA inspection report
- The sponsor's audit history from prior studies
Correct answer: The study protocol, relevant SOPs, and any previously issued protocol amendments
Effective audit preparation requires reviewing the protocol, applicable SOPs, and all amendments to know what requirements apply to the phase being audited.
Question 6: In the SQA professional community, what does 'mutual recognition' of GLP compliance refer to?
- An agreement between countries to accept each other's GLP inspections and study data without duplication (Correct answer)
- A reciprocal audit arrangement between two test facilities
- FDA and EPA jointly accepting the same study for submission
- Sponsors and test facilities jointly certifying study compliance
Correct answer: An agreement between countries to accept each other's GLP inspections and study data without duplication
OECD GLP mutual recognition allows signatory countries to accept nonclinical safety studies conducted under GLP in other member countries.
SQA SQA Inspector Roles and Responsibilities 2
Which skill is most critical for a QA inspector when reviewing laboratory raw data for GLP compliance?