Part 5- Current Good Laboratory Practice Regulations 2023 Update

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 Continues...