glp: Good Laboratory Practice (GLP) for non-clinical drug research is the basic guideline that must be followed for preclinical research on drugs. It includes a series of behaviors and laboratory normative requirements for experimental design, operation, recording, reporting, and supervision of drug safety evaluation in non-clinical drug research. It is to improve the quality of new drug research from the source and ensure the safety of people's drug use. fundamental measures.
GLP certification is divided into three major links: application and acceptance, document review and on-site inspection, and audit and announcement.
After the applicant organization submits the application materials in accordance with the regulations and meets the requirements after review of the materials, it will undergo on-site inspection. The on-site inspection time for GLP certification generally lasts 3 to 4 days, and there are 3 to 5 inspectors. The head of the organization's quality assurance department should accompany the inspection team during the inspection, be responsible for communication between the inspection team and the organization, and be able to answer or contact relevant personnel Answer relevant questions raised by the inspection team. GLP on-site inspection methods include on-site inspection of experimental facilities and equipment, assessment of researchers' GLP and other related non-clinical trial knowledge and experimental skills, review of SOP and other document systems, and inspection of whether the trial projects undertaken comply with GLP, etc.