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. What is 'process capability' as measured by Cpk? → A measure of how well a process meets specification limits relative to its variability
3. Which professional designation is offered by SQA to recognize demonstrated competency in quality assurance? → Registered Quality Assurance Professional (RQAP-GLP)
4. In the PDCA (Plan-Do-Check-Act) cycle, what is the primary purpose of the 'Check' phase? → To evaluate results against the planned objectives
5. What trait does a test for quality assurance look for in applicants? → Proficiency in key areas important for a Quality Assurance specialist
6. What is a 'Certificate of Conformance' (CoC) used for in quality assurance? → To attest that a product or service meets specified requirements
7. 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
8. How must superseded (outdated) SOPs be handled under GLP? → Retained in archives with the date of supersession noted
9. 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
10. 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
11. During a for-cause inspection, FDA investigators request all emails related to a batch failure. The QA manager should: → Consult legal counsel and provide requested records in accordance with applicable law
12. Which method validation parameter measures how close test results are to the true value? → Accuracy
13. 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%)
14. 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
15. Under 21 CFR Part 11, which of the following is NOT a requirement for electronic signatures? → The signature must be witnessed by a supervisor
16. Under US GLP regulations, which agency has GLP oversight authority for pesticide studies submitted under FIFRA? → U.S. Environmental Protection Agency (EPA)
17. Which audit technique involves direct observation of study personnel performing their tasks? → Witnessing
18. 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
19. A laboratory analyst discovers a chromatographic peak that was not present in the system suitability blank. The FIRST action should be: → Report the finding to QA and document the observation before taking further action
20. 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
21. How does a Quality Assurance test assist in evaluating a candidate's qualifications? → The candidate's technical abilities
22. 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
23. 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
24. 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
25. Which concept requires that pharmaceutical manufacturing processes consistently reproduce output meeting predetermined specifications? → Process Validation
26. What are the three stages of FDA's current process validation lifecycle framework (2011 Guidance)? → Process Design, Process Qualification, and Continued Process Verification
27. What is required when computerized systems are used to collect GLP raw data? → Validation of the system, access controls, audit trails, and backup procedures
28. 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
29. 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
30. 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