Labeling is an integral part of the manufacture and sales of drugs and medial devices. The label provides product identification, instructions for use and safety information. Because the label is frequently the first point of contact for patients, medical practitioners, and many other people who handle packages throughout the supply chain, labeling for drugs and medial devices is highly regulated by the FDA and governed by a variety of standards from organizations such as ASTM and ANSI.
Brand owners need to ensure their labeling process complies with all applicable regulations and meets a high bar for quality to ensure reliable labeling throughout the lifecycle of the product. For this reason, label qualification is an essential step; executing a well-planned label material and print qualification will ensure that your product labeling remains intact during distribution, storage, and dispensing.