GLP Regulations and Compliance Flashcards

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

Answer: Study protocol signed by both sponsor and Study Director

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

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

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

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

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

Answer: All personnel involved in the conduct of the study

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

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

Answer: Identity, strength, purity, composition, and stability

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

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

Answer: Archives

GLP regulations require that archives for raw data and specimens be physically separate from active laboratory areas.

Under OECD GLP Principles, which term describes an auditable record of the chronological history of a study?

Answer: Raw data

Raw data, as defined under OECD GLP, constitutes the original first-hand records and documentation that form the chronological audit trail of a study.