GLP 2023

GLP 2023 Good Laboratory Practice - deals with how nonclinical laboratory studies are planned, performed, monitored, and recorded. 1976: Industrial Bio‐Test Laboratories (IBT) - Fabrication of data Replacement of dead study animals with healthy ones Changes in raw data to make them fit the result tables i Regulations for Good Laboratory Practices (GLP) were created when and why - 1979 Poorly‐trained Study Directors and study personnel Poorly‐designed protocols Protocols not followed Raw data badly collected GLP regulations apply to non‐clinical research studies such as - Acute, subacute, and chronic tox studies Reproductive tox studies Genotoxicity (Mutagenicity) testing Carcinogenicity Pharmacokinetic studies Pharmacodynamic studies testing adverse effects In 1981, Organization for Economic Cooperation and Development (OECD - produced GLP principles that are similar to those of the FDA Instituted for non‐US companies that wanted to sell drugs in the United States GLP goal - To help scientists obtain results that are reliable, repeatable, auditable, and recognized world‐wide. Required Organization and Personnel - Each study must have an assigned Study Director Quality Assurance personnel Quality Assurance personnel - One person not directly involved in the study to monitor research processes A signed QA report is filed with each study report Facilities Requirements - Must be of adequate size and have all the proper equipment to perform the study Environmental controls exist for controlling air quality and contaminants Design and maintenance of equipment - All aspects of the equipment used in the study must be recorded • Maintenance • Calibration • Standardization and records should include things like -model -serial number -person responsible for equipment -date placed in service -if SOPs were followed Testing facilities operation - Standard Operating Procedures (SOPs) Quality Assurance Unit (QAU): Standard Operating Procedures (SOPs) - written protocols on how all aspects must be carried out Typical SOPs - Routine inspection, cleaning, maintenance, testing, calibration Actions to be taken in response to equipment failure Definition of raw data Health and safety precautions Record keeping, reporting, storage, and retrieval of data Quality Assurance Unit (QAU): - serves as an internal control; monitors entire study to ensure it complies with GLP Continues...