Part 5- Current Good Laboratory
Practice Regulations 2023 Update
What is the purpose of GLP regulations? - ANS-Compliance with GLP is intended to
assure the quality and integrity of safety data filed with federal re
...
Part 5- Current Good Laboratory
Practice Regulations 2023 Update
What is the purpose of GLP regulations? - ANS-Compliance with GLP is intended to
assure the quality and integrity of safety data filed with federal regulatory agencies.
What are 6 types of products that are subject to GLP regulations during testing? - ANSFood and colour additives
Animal food additives
Human and animal drugs
Medical devices for human use
Biological products
Electronic products (used for food, drug or medical purposes)
What is a non-clinical laboratory study? - ANS-Any in vitro or in vivo study in which the
test article is being studied in a test system under laboratory conditions to determine its
safety. This doesn't include any clinical studies using humans or animals or any basic
preliminary studies to determine potential efficacy (discovery phase).
Who performs non-clinical laboratory studies? - ANS-A sponsor performs the study.
This can include:
A person/group who initiates and supports the study
A person who submits a nonclinical study to the FDA via an application for research
marketing
A testing facility, if it both initiates and conducts the study.
Where is a nonclinical study conducted? What is required of this location? - ANS-In a
testing facility, which is an establishment that is required to register itself as a
nonclinical GLP lab under relevant sections of the Federal food, drug and cosmetic act.
What is management responsible for with regards to GLP (6 things)? - ANS-Study
director designation
Quality assurance unit must be present
Ensuring that test and control articles have been properly analyzed and handled
Assuring that personnel, resources, facilities, equipment, materials and methods are
available
Assuring that personnel are properly trained
Assuring that deviations from GLP are reported to the study director and corrective
actions are taken/documented
What are the four types of personnel in a nonclinical study under GLP? - ANS-Standard
personnel
Management
Study director
Quality Assurance Unit...
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