SQA Startup 3

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?

Accepted Answer

Confirming identity, strength, purity, and stability of test articles

Answer

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?

Accepted Answer

Before the procedure is performed in the study

Answer

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?

Accepted Answer

To verify the study is properly registered and scheduled

Answer

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?

Accepted Answer

Animal room environmental controls (temperature, humidity, light cycles)

Answer

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?

Accepted Answer

To oversee specific phases of the study conducted at their site

Answer

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.

SQA - Society of Quality Assurance Practice Test

SQA - Society of Quality Assurance Practice Test

SQA Startup 3