SQA Cheat Sheet 2026

The 30 highest-yield SQA facts, distilled from real exam questions. Print it, save it as a PDF, or study it here — free, no sign-up.

1. Under GLP, how should multiple samples from the same animal or subject be differentiated in raw data? → By unique individual identification such as animal number, sample code, or collection time
2. Which professional designation is offered by SQA to recognize demonstrated competency in quality assurance? → Registered Quality Assurance Professional (RQAP-GLP)
3. What trait does a test for quality assurance look for in applicants? → Proficiency in key areas important for a Quality Assurance specialist
4. In a GLP nonclinical study, which document is used to formally transfer responsibility from the sponsor to the test facility? → Study protocol signed by both sponsor and Study Director
5. How must superseded (outdated) SOPs be handled under GLP? → Retained in archives with the date of supersession noted
6. Which regulatory pathway allows a sponsor to request FDA agreement on the acceptability of a nonclinical testing program before studies are conducted? → Pre-IND meeting with FDA to discuss the nonclinical development plan
7. Which startup activity ensures that the test system (e.g., animals, cells) meets the protocol specifications before study procedures begin? → Test system acclimation and characterization
8. Which method validation parameter measures how close test results are to the true value? → Accuracy
9. What factors in a Quality Assurance test increase a candidate's likelihood of being invited to the following stages of the recruiting process? → Performing well in the test (typically in the top 50%)
10. In GLP, what is the required outcome if a test article mixture is prepared at study startup and homogeneity cannot be confirmed? → Do not use the mixture until homogeneity is analytically confirmed
11. Under US GLP regulations, which agency has GLP oversight authority for pesticide studies submitted under FIFRA? → U.S. Environmental Protection Agency (EPA)
12. Which audit technique involves direct observation of study personnel performing their tasks? → Witnessing
13. Under GLP, which facility personnel must be sufficiently trained and qualified to perform their assigned functions? → All personnel involved in the conduct of the study
14. During startup, a laboratory discovers that a required piece of equipment is out of calibration. What must occur before the study proceeds? → Calibrate, verify accuracy, and document before use
15. How does a Quality Assurance test assist in evaluating a candidate's qualifications? → The candidate's technical abilities
16. Which of the following scenarios constitutes a data integrity violation in a GLP study? → Pre-dating a laboratory notebook entry to match when the experiment was originally planned
17. Which FDA guidance document provides the agency's current thinking on GLP regulations for nonclinical laboratory studies? → FDA's Bioresearch Monitoring compliance program guidance manuals for GLP inspections
18. What does a sample report look like that comes out of a quality assurance test? → Results for the Quality Assurance Test along with other assessments in a candidate report
19. Which concept requires that pharmaceutical manufacturing processes consistently reproduce output meeting predetermined specifications? → Process Validation
20. What are the three stages of FDA's current process validation lifecycle framework (2011 Guidance)? → Process Design, Process Qualification, and Continued Process Verification
21. What is required when computerized systems are used to collect GLP raw data? → Validation of the system, access controls, audit trails, and backup procedures
22. Which GLP record created at study startup provides a direct link between the study protocol and individual raw data entries throughout the study? → The specimen label and unique sample identification system
23. When a QA inspector discovers that a study was conducted without a signed, approved protocol, what classification of GLP issue does this represent? → A critical GLP nonconformance because the protocol is required before study initiation
24. 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
25. Which activity must occur before an auditor can close a previously identified nonconformance? → Verification that the corrective action has been effectively implemented
26. 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
27. Non-functional testing can take the following forms, with the exception of: → None of these
28. What kinds of questions are on a test for quality assurance? → Multiple-choice questions
29. Which document defines step-by-step instructions for performing a laboratory test method? → Standard Operating Procedure (SOP)
30. When a test facility receives a study sponsor's protocol amendment during startup, what is the FIRST action required under GLP? → Review, approve, and sign the amendment before proceeding