Pharmaceutical and medical device manufactures are legally required to follow certain product coding and marking regulations. Governing bodies such as the U.S. Food and Drug Administration (FDA) develop and administer these mandates.
When products escape the labeling and packaging component of a manufacturer’s production system, recalls happen! In fact, in a recent FDA presentation, it was found that the causes for some recall events (and their percentage of total recalls) identified as follows:
Pharmaceutical track & trace systems play an important role in diminishing the occurrence of these non-conformances. Printing Verification and Control Devices can be used:
A robust packaging and labeling system:
For a guide to provide direction to sponsors, manufacturers and license holders in designing safe and clear labels and packages, see Government of Canada’s Good Label and Package Practices Guide for Prescription Drugs.
With RN Mark printers, you can quickly and accurately code your products at all levels. From marking the product itself all the way to final packaging.
The FDA requires devices intended to be reprocessed or to be used more than once by multiple patients to be marked with a permanent Unique Device Identifier (UDI). This is known as UDI direct marking. The most reliable way to ensure a UDI lasts for the life of a multi-use device is by marking the device itself with a permanent mark, rather than a temporary package or label which can be discarded, torn, obscured, wiped off, or easily degraded.