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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 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.
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 ...
Good distribution practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use. 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
The Clinical and Laboratory Standards Institute (CLSI) is a volunteer-driven, membership-supported, not-for-profit, standards development organization. CLSI promotes the development and use of voluntary laboratory consensus standards and guidelines within the health care community.
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