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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 addresses the requirements for label design. The manufacturer needs to make sure the label is constructed and printed so that legibility is assured under normal conditions and use over the life of the device. The purchase specifications need to identify what label substrate is to be used, label dimensions, ink used, the label finish and how the label is mounted on the roll.
ISO 13485 requires a company to identify the product throughout the manufacturing process. Included in this is a need for a defined process for labeling and packaging.
Once received, all packaging and labeling materials must be examined and tested to verify that they meet the requirements in the purchase specifications. The incoming inspections need to be documented to provide proof of conformance verification. These items can include pre-printed containers, inserts and pre-printed packaging materials. The manufacturing processes that involve labeling and packaging should be separated to ensure there are not any mix-ups between similar product and/or labels. Any unused labeling that contains lot-specific information should be destroyed instead of being returned to the label storage area.
Labeling information is an official part of the Device Master Record. Because of this, any changes to labels or labeling must be made through the change control system. This will enable the changes to be reviewed and authorized by the appropriate individuals prior to implementation.
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