Animal experiment facilities refer to the sum of buildings, equipment, and operation management for the purpose of research, experimentation, teaching, biological products and pharmaceutical production, etc., for the breeding and experimentation of experimental animals. Its management is very important for applying for GLP certification. Companies that rank high in China’s GLP organization will undoubtedly pay more attention to this. According to the “Certification Management Measures”, pre-clinical safety evaluation research institutions should have test facilities and equipment suitable for the declared safety test items.
GLP is an important measure for my country’s drug safety evaluation standards to be in line with international standards. The GLP standard is an internationally recognized passport. Without a laboratory that meets the GLP requirements, there can be no bilateral or international recognition. The top companies in the ranking of China’s GLP institutions have a high level of GLP management and can escort the clinical research of new drugs. Medicilon provides new drug R&D outsourcing services. It is a CRO company that provides a complete set of pre-clinical approval documents and complies with the Chinese GLP and U.S. GLP standards.
Article 9 of my country’s “Non-clinical Drug Research Quality Management Regulations” requires that drug safety evaluation agencies should: “Have a reasonable design and appropriate configuration of animal breeding facilities, and be able to regulate temperature, humidity, air cleanliness, ventilation and lighting as needed. Environmental conditions. The conditions of laboratory animal facilities should be consistent with the level of laboratory animals used.” According to the results of 42 on-site inspections of GLP certification held by the Center for Drug Certification and Administration of the State Food and Drug Administration in 2014, the following problems often exist in animal testing facilities during GLP certification inspections.
The barrier system of the animal room has problems such as the absence of UV lamps in the transmission window, the lack of pressure difference records, temperature and humidity monitoring and environmental monitoring facilities, and the unreasonable flow of clean items, accounting for about 63% of the tested laboratories. In terms of animal facilities, there are problems such as excessive ammonia concentration in large animal rooms, storage of feed and animal drinking water in the same room, and simple control of light with curtains.
The problem of experimental facilities accounted for about 40% of the tested laboratories. Among them, the archives and specimen rooms were not equipped with anti-theft devices, which accounted for 31% of the tested laboratories; the lack of test product analysis and testing laboratories accounted for about 31% of the tested laboratories. 9% of the room.
Approximately 18% of the inspected laboratories lack status identification of instruments and equipment; about 18% of the inspected laboratories have weights used to calibrate the balance without verification; the instrument and equipment files are incomplete, especially the 3Q verification data. About 50% of the tested laboratories are involved in such problems; about 5% of the tested laboratories are uncertified for pipettes.
The animal experiment facilities should meet the national standards for the environment of experimental animal facilities, and pass the inspection and acceptance of the provincial (municipal) level experimental animal management committee and obtain the experimental animal use license.
The storage rooms for feed, bedding, and breeding equipment should be set up separately outside the animal breeding room, and have the conditions for preventing insects, corrosion, and pollution. The area of the dissection room and operating room should be large enough, close to the animal experiment area, and outside the barrier system. At the same time, it should be equipped with facilities such as offices and scrubbing rooms.
Through the use of central air conditioning, ventilation and purification systems to maintain and ensure the stability of the temperature and humidity, ventilation and cleanliness of the animal laboratory environment. As the air conditioning, ventilation and purification equipment is very professional, it needs to be equipped with professionals for maintenance and repair, and there are personnel on duty 24 hours.
For animal experiment facilities, GLP requires a complete set of temperature, humidity, pressure monitoring and recorders, which can be stored on a computer or CD-ROM, and units with conditions can install a camera monitoring system. GLP stipulates that experimental facilities must have a dual-circuit power supply system to prevent sudden power outages from affecting animal experiments. If there is no dual power supply system, it can be equipped with a generator that can be used temporarily in the event of a power failure. The power system needs to have staff on duty 24 hours.
The special instruments for animal breeding rooms mainly include autoclaves, electronic scales, thermometers and hygrometers. These are all measuring instruments and require mandatory inspection and calibration every year. In addition, the autoclave is a pressure vessel and requires a use license issued by the Quality and Technical Supervision Bureau. The operator must be trained and certified to work. The instrument and equipment have detailed records of purchase, installation, acceptance, use, maintenance, calibration, and repair. And archive. For cages and cages for keeping animals, the size must comply with national standards and must not be less than the specified area and height.
The implementation of GLP can effectively standardize the organization and management of non-clinical drug research and ensure the reliability, completeness and repeatability of experimental results. The widespread implementation of GLP in the field of pharmacology and toxicology research is also a general trend. Therefore, research institutions should still expand their comprehensive understanding of the quality system of drug non-clinical research, strengthen the depth of GLP training, and effectively improve the quality of drug safety research.
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