GLP, non-clinical quality management practices for drugs, is the basic principle that drugs must follow for pre-clinical research. At present, the distance between my country’s GLP organization, China GLP, and developed countries such as the United States, has gradually narrowed, and the organization that ranks first in China’s GLP organization also affirms the strength of the organization, and the value created through its strength has been recognized by customers. In the GLP certification, the animal room is an important department of the safety evaluation center. Almost most safety evaluation projects are completed through animal experiments. In order to ensure that each raw data of animal experiments is true and reliable, it is necessary to do well in laboratory animals. Feeding and management work.
The feeding and management of laboratory animals includes animal procurement, acceptance and quarantine, daily feeding management, and animal supplies management. Medicilon is a pre-clinical CRO company that ranks high in China’s GLP institutions. It is a CRO company that provides a complete set of pre-clinical approval documents and meets the Chinese GLP and U.S. GLP standards.
Animal laboratories shall purchase animals according to the requirements of the person in charge of the subject. The type, strain, gender, age, weight, nutritional status, and health level of the purchased experimental animals shall meet the requirements of experimental research. It is best for animal laboratories to establish a fixed business relationship with a reputable laboratory animal supplier that holds an animal production license, and requires the supplier to regularly provide production licenses and test reports and archive them. According to the regulations in the GLP inspection method, the rats and mice used in the safety evaluation test should meet the SPF level, the guinea pigs should meet the clean level, and the rabbits and dogs should meet the general level.
After the experimental animals arrive in the animal laboratory, they must be packaged and sterilized, and sent to the animal quarantine room for observation through the animal-specific delivery window. After quarantine and observation, animals that are confirmed to be normal can be transferred to the breeding room. However, for large animals that are found to have individual abnormalities during quarantine observation or experimentation, they should be taken out and placed in an isolation room for isolation observation and treatment. The quarantine observation period is 3 d acute toxicity test in mice, 7 d long-term toxicity test in rats, 3 d local irritation test in rabbits, and 14 d long-term toxicity test in dogs. During the quarantine observation period, the observation items should be detailed and kept on file, including skin and coat, appearance, food intake, drinking water, excrement, natural holes, touch inspection, etc.
The animal laboratory is responsible for the management of the entire animal experiment, including the registration of personnel entering and exiting, the cleaning and disinfection of cages and equipment, sterile clothing, the recording of temperature and humidity, and the pressure difference in the breeding room, the observation of animals, the feeding and water supply and the replacement of cages, and the breeding area The cleaning, sanitation and disinfection, as well as the cleaning and disinfection after the experiment.
Generally speaking, it is best to arrange only one experiment in a breeding room of a barrier facility. When the same animal with different themes has to be kept in the same breeding room, appropriate separation measures should be adopted, such as the use of breeding equipment such as IVC, and There are marks, such as filling in different cage cards, etc. The test products, syringes, gastric gavage needles and other instruments used should also be strictly separated. Storage and use of articles All spare articles after sterilization and disinfection shall be placed in the inner preparation room. The articles shall be stacked neatly, and the inner preparation room shall be clean and dry. Labels should be attached to the sterilized items every day, indicating the date of sterilization, and the sterilized items should be used up within 1 week.
The expired unused items should be re-sterilized. The reagents and solutions in the laboratory are labeled with the product name, concentration, storage conditions, preparation person, preparation date and expiration date, etc. In the management of barrier environment animal facilities, GLP pays special attention to the control of the flow of people, logistics, animal flow, air flow and temperature, humidity, and pressure difference. At the entrance of each breeding room, there should be a clean corridor for the differential pressure gauge of the breeding room and the identification information of a certain topic in the breeding room.
The quality of feed, litter and water is stipulated in Article 19 of the “Non-clinical Drug Research Quality Management Regulations” that animal feed and drinking water should be inspected regularly to ensure that they meet nutritional and hygienic standards. The pollution factors that affect the experimental results should be lower than the specified limits, and the inspection results should be kept as original data. The drinking water of experimental animals raised in the barrier and isolation environment must be sterilized.
The litter should meet the conditions of good moisture absorption, low dust, no odor, no toxicity, no grease, high temperature resistance, high pressure resistance, etc., and use after sterilization and insecticide to ensure that it has no influence on the experiment. The litter should be changed frequently, and the animal boxes and cages should be kept clean and dry. The temperature of the feed storage room should be lower than normal temperature, the feed and litter should comply with the principle of first in, first out, and the entry and exit records should be filled in carefully. Animal breeding boxes, cages, racks and other animal supplies should be cleaned and disinfected regularly, but should not affect the results of the experiment, and the name, concentration, use method and use time of the detergent and disinfectant should be recorded in detail.
Animal feeding will produce a lot of waste, generally including: animal excrement, animal carcasses, medical waste and general garbage. Whether these wastes can be properly handled is also an important aspect of GLP inspection. Except for ordinary household garbage, which can be generally treated as follows, animal carcasses should be treated in a harmless manner; animal carcasses and tissues for infectious animal experiments must be autoclaved and then sent out to the laboratory for corresponding treatment (or handed over to the environmental protection department for disposal). Disposable overalls, masks, gloves and experimental wastes should be treated in a harmless manner in accordance with the hospital’s sewage disposal regulations. Sharp objects such as injection needles and blades should be collected in a sharps box for unified disposal. The feces of large animals such as dogs and rabbits are flushed into the sewage pipe, and then discharged into the urban drainage system after the sewage is treated.
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