SQA GLP Regulations and Compliance 3

Question 1

In a GLP nonclinical study, which document is used to formally transfer responsibility from the sponsor to the test facility?

Accepted Answer

Study protocol signed by both sponsor and Study Director

Answer

Material Transfer Agreement

Answer

GLP compliance statement

Answer

Certificate of Analysis

Question 2

What action is required when a GLP deviating circumstance occurs during a study?

Accepted Answer

Document the deviation, assess its impact, and report it in the final study report

Answer

Terminate and restart the study

Answer

Notify the FDA immediately

Answer

Transfer the study to another facility

Question 3

Under GLP, which facility personnel must be sufficiently trained and qualified to perform their assigned functions?

Accepted Answer

All personnel involved in the conduct of the study

Answer

Only the Study Director and principal investigators

Answer

Only personnel handling test articles

Answer

Only QAU staff

Question 4

What is required to be included in the characterization records of a test article under GLP?

Accepted Answer

Identity, strength, purity, composition, and stability

Answer

Only the CAS registry number

Answer

Trade name and manufacturer only

Answer

Shipping documentation and storage temperature

Question 5

Which GLP facility area must be separate from areas where the test and control articles are handled?

Accepted Answer