Biosafety Levels, BSLs 
This is a classification standard for organisms with infectious risks according to their hazard levels. It categorizes the necessary facilities and protective equipment based on factors such as infectivity, severity, disease, and transmissibility. The classification follows four biosafety levels—BL1, BL2, BL3, and BL4—according to criteria established by the World Health Organization (WHO) or the U.S. Centers for Disease Control and Prevention (CDC).
- Biosafety Laboratory Grades
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Classification and facility requirements follow WHO, CDC, and relevant national biosafety regulations for genetically modified organisms and infectious agents.
Grade
(Permit/Report)Target Facilities Description Grade 1 (Report) Facilities conducting experiments using genetically modified organisms (GMOs) that are known** not to cause disease in healthy adults** or harm the environment. Facilities conducting experiments with GMOs developed from such organisms. Grade 2 (Report) Facilities conducting experiments using GMOs that may cause disease in humans but are generally treatable. Even if released, the risk is limited and treatment is available. Experiments with GMOs developed from such organisms are performed here. Grade 3 (Permit) Facilities conducting experiments using GMOs that can cause serious illness or death in humans if released into the environment, but for which effective treatments or preventive measures are available. Experiments with GMOs developed from such organisms. Grade 4 (Permit) Facilities conducting experiments using GMOs that can cause severe or fatal disease in humans and for which treatment or preventive measures are generally not available. Experiments with GMOs developed from such organisms, with stringent containment.
- Good Laboratory Practice (GLP)
- Good Laboratory Practice refers to a quality system encompassing the organizational processes and conditions under which non-clinical laboratory studies are planned, performed, monitored, recorded, reported, and archived. These principles apply to non-clinical safety testing of substances present in various products to ensure the quality, reliability, and integrity of safety data submitted to regulatory authorities globally.
- Good Clinical Practice (GCP)
- Good Clinical Practice is a set of clinical trial management standards designed to ensure that clinical trials are conducted in compliance with scientific rigor and ethical principles. To conduct a clinical trial, facilities such as an investigational product storage room, document archive, monitoring room, and laboratory must be in place, and the temperature and humidity specified by the trial sponsor must be consistently and regularly maintained.
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