SQA GLP Regulations and Compliance 3 — Questions and Answers
Question 1: In a GLP nonclinical study, which document is used to formally transfer responsibility from the sponsor to the test facility?
- Study protocol signed by both sponsor and Study Director (Correct answer)
- Material Transfer Agreement
- GLP compliance statement
- Certificate of Analysis
Correct 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.
Question 2: What action is required when a GLP deviating circumstance occurs during a study?
- Document the deviation, assess its impact, and report it in the final study report (Correct answer)
- Terminate and restart the study
- Notify the FDA immediately
- Transfer the study to another facility
Correct 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.
Question 3: Under GLP, which facility personnel must be sufficiently trained and qualified to perform their assigned functions?
- All personnel involved in the conduct of the study (Correct answer)
- Only the Study Director and principal investigators
- Only personnel handling test articles
- Only QAU staff
Correct 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.
Question 4: What is required to be included in the characterization records of a test article under GLP?
- Identity, strength, purity, composition, and stability (Correct answer)
- Only the CAS registry number
- Trade name and manufacturer only
- Shipping documentation and storage temperature
Correct answer: Identity, strength, purity, composition, and stability
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?
- Archives (Correct answer)
- Animal care area
- Necropsy room
- Chemistry laboratory
Correct answer: Archives
GLP regulations require that archives for raw data and specimens be physically separate from active laboratory areas.
Question 6: Under OECD GLP Principles, which term describes an auditable record of the chronological history of a study?
- Raw data (Correct answer)
- Study plan
- Signed protocol
- QA compliance certificate
Correct 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.
SQA GLP Regulations and Compliance 3
In a GLP nonclinical study, which document is used to formally transfer responsibility from the sponsor to the test facility?