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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]
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.
Nationally Recognized Testing Laboratory is the term used by the United States Occupational Safety and Health Administration to identify third-party organizations that have the necessary qualifications to perform safety testing and certification of products covered within OSHA and each organization's scopes.
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent.
Good laboratory practice (GLP), for laboratories conducting non-clinical studies (toxicology and pharmacology studies in animals) Good pharmacovigilance practice (GVP), for the safety of produced drugs; Good regulatory practice (GRP), for the management of regulatory commitments, procedures and documentation
The enforcement and training on such regulations can vary from lab to lab based on the State's plans for occupational health and safety. With the exception of DoD lab personnel, CDC lab personnel, First responders, and DoT employees, enforcement of training is inconsistent, and while training is required to be done, specifics on the breadth and ...
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