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

The signed protocol, bearing both sponsor and Study Director signatures, documents the transfer of study responsibility.

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

GLP requires that unexpected events be documented in raw data, their impact assessed, and deviations reported in the final study report.

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

GLP regulations require that all personnel have education, training, and experience appropriate to their role in the study.

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

GLP requires test article characterization records to include identity, strength, purity, composition, and stability data.

Question 5

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

Accepted Answer

SQA - Society of Quality Assurance Practice Test