Label Example

Device Labeling

Manufacturers are required to have labels for product and product labeling.  According to the FDA in section 201, a label is a “display of written, printed, or graphic matter upon the immediate container of any article” whereas “labeling includes equipment labels, control labels, package labels, directions for use, maintenance manuals, etc.” 21 CFR 820 specifically…

Clean Room

Control of Equipment

As part of a company’s quality management system, there must be consideration for the equipment used within the facility.  According to the FDA’s 21 CFR 820, “Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked and maintained.”  They also have the requirement that all inspection, measuring and test…

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Management Representative

The FDA has a requirement, in 21 CFR 820.20, for a Management Representative.  This individual “irrespective of other responsibilities, shall have established authority over and responsibility for:  Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and Reporting on the performance of the quality system to management with…

Depyrogination

Validation of Dry Heat Sterilization Processes

Dry Heat Sterilization is a sterilization process that can be used to terminally sterilize health care products, medical devices, equipment, components or bulk active pharmaceutical ingredients by exposing the items to a temperature of ≥ 160°C for a defined time. For heat stable items, such as glassware or stainless steel equipment, a dry heat sterilization cycle…

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Friday Facts – Non-Conformances

Both 21 CFR 820 and ISO 9001 require a company to have control over their non-conforming product.  According to the FDA, “each manufacturer shall establish and maintain procedures to control product that does not conform to specified requirements.”  Essentially, a company must have a procedure in place that addresses the identification, documentation, evaluation, segregation and…