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Hazardous chemicals present physical and/or health threats to workers in clinical, industrial, and academic laboratories. Laboratory chemicals include cancer-causing agents (carcinogens), toxins (e.g., those affecting the liver, kidney, and nervous system), irritants, corrosives, sensitizers, as well as agents that act on the blood system or damage the lungs, skin, eyes, or mucous membranes.
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
A certificate of analysis (COA) is a formal laboratory-prepared document that details the results of (and sometimes the specifications and analytical methods for) one or more laboratory analyses, signed—manually or electronically—by an authorized representative of the entity conducting the analyses. This document gives assurances to the ...
Secondly, the laboratory supervisor, who reports to the laboratory director, is responsible for organizing regular training sessions on laboratory safety. [9] The third point, the personnel must be informed about any special hazards and be required to review the safety or operations manual and adhere to established practices and procedures. The ...
Issued to a laboratory to allow the laboratory to conduct nonwaived (moderate and/or high complexity) testing until the laboratory is surveyed (inspected) to determine its compliance with the CLIA regulations. Only laboratories applying for a certificate of compliance or a certificate of accreditation will receive a certificate of registration. CoC
A laboratory-specific biosafety manual must be drafted which details how the laboratory will operate in compliance with all safety requirements. [ 21 ] All laboratory personnel are provided medical surveillance and offered relevant immunizations (where available) to reduce the risk of an accidental or unnoticed infection.