SQA Startup 3 — Questions and Answers
Question 1: Under FDA GLP regulations (21 CFR Part 58), which startup action must be completed to establish that test and control articles are properly characterized?
- Obtaining sponsor invoices
- Confirming identity, strength, purity, and stability of test articles (Correct answer)
- Signing the final report
- Completing the QA audit certificate
Correct answer: Confirming identity, strength, purity, and stability of test articles
Test articles must be characterized for identity, strength, purity, and stability before use in a GLP study.
Question 2: A new SOP is needed for a procedure that will be performed during a study. When must this SOP be approved relative to study startup?
- After the study is complete
- Before the procedure is performed in the study (Correct answer)
- During the final audit
- At the sponsor's discretion
Correct answer: Before the procedure is performed in the study
SOPs must be approved and in place before any procedure they govern is conducted in the study.
Question 3: During startup, the QA unit reviews the Master Schedule. What is the primary purpose of this review?
- To assign billing codes to the study
- To verify the study is properly registered and scheduled (Correct answer)
- To approve final raw data
- To nominate the Study Director
Correct answer: To verify the study is properly registered and scheduled
The Master Schedule review confirms that the study is correctly registered, preventing scheduling conflicts and ensuring GLP traceability.
Question 4: Which element of facility readiness is most critical to verify at startup for an in-vivo GLP toxicology study?
- Marketing clearance documentation
- Animal room environmental controls (temperature, humidity, light cycles) (Correct answer)
- Sponsor's financial audit records
- Publication strategy
Correct answer: Animal room environmental controls (temperature, humidity, light cycles)
Environmental conditions in animal rooms must meet protocol and regulatory requirements to ensure test system validity.
Question 5: What is the role of the Principal Investigator (PI) at study startup in a multi-site GLP study?
- To replace the Study Director at the main facility
- To oversee specific phases of the study conducted at their site (Correct answer)
- To prepare the final integrated report
- To audit all other sites
Correct answer: To oversee specific phases of the study conducted at their site
In a multi-site study, the PI is responsible for the phases of the study conducted at their facility under the Study Director's overall direction.
Question 6: If a GLP study protocol lacks a section describing statistical methods to be used, what should the QA unit recommend at startup?
- Proceed and add statistics at the end
- Reject the entire study permanently
- Request a protocol amendment to include the statistical methods before data collection (Correct answer)
- Allow the sponsor to decide after data analysis
Correct answer: Request a protocol amendment to include the statistical methods before data collection
Statistical methods must be defined in advance; a protocol amendment should be issued to include them before data generation begins.
Question 7: Which statement about reagent and reference standard management at study startup is consistent with GLP requirements?
- Expiry dates can be ignored if the reagent appears normal
- Reagents must have confirmed identity, concentration, and expiry before use (Correct answer)
- Reagents are characterized only after the study concludes
- Only controlled substances require expiry tracking
Correct answer: Reagents must have confirmed identity, concentration, and expiry before use
GLP requires that all reagents and standards be properly labeled with identity, concentration, and expiry, and verified before use.
SQA Startup 3
Under FDA GLP regulations (21 CFR Part 58), which startup action must be completed to establish that test and control articles are properly characterized?