Laboratory safety management is about being alert and on one’s toes all the time and every time. This is easier said than done, because laboratories, being the location at which various tests and experiments take place, are a source of many dangers and contaminants.
Laboratory safety management is imbibed in Good Laboratory Practices (GLP). In addition, laboratories have to also comply with guidelines set out in Section 5(a) (1) of the Occupational Health Act (OSHA) of 1970, which requires employees to “furnish to each of employees employment and a place of employment which are free from recognized hazards that are causing or likely to cause death or serious physical harm to his employees”.
FDA guidelines on laboratory safety management
The FDA has guidelines on laboratory safety management. Covered under 21 CFR 58; laboratory safety management guidelines cover areas such as animal testing, animal health products, and other test articles, but exclude cosmetics and processed foods, although broadly speaking, they are also laboratory practices. Also, FDA guidelines on laboratory safety management do not regulate on the nature of sponsor and contractor of a clinical trial. It leaves it to the parties to devise ways by which they work with each other. Adherence to both these is a requirement of laboratory safety management.
Employer’s responsibility under OSHA
As part of OSHA, employers who employ personnel in laboratories have to ensure that employers are not exposed to agents of hazard, such as chemicals and fire. Laboratory safety management is further fortified by regulations covering potentially hazardous objects such as naked flames (such as Bunsen burners), sharps, glassware, hot surfaces, pressurized gas cylinders, and heat from exothermic reaction and very cold media, including cryogenic liquids.
What happens when laboratory safety management guidelines are not adhered to?
When the FDA finds out that a laboratory is infringing on laboratory safety management practices and guidelines, it issues that lab a 483. This is a note to the facility to state that it is not in compliance with FDA guidelines in this regard. After deliberation of the 483; the FDA gives the lab some time to correct its discrepancies. If a lab fails at this, it is deemed to be noncompliant with laboratory safety management principles, and legal action follows.
OSHA has its own prescriptions for labs that do not adhere to its guidelines. It suggests suitable penalties and ways by which to take corrective measures within a timeframe, allowing the company to implement sound laboratory safety management principles.
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