A prescription, biological, device and consumer product label plays scores of roles starting from providing basic identification of the product to providing critical usage instructions, special warnings, purpose of the product, patient education and medication adherence to providing anti-counterfeiting features. End-users of the label can be physicians, health care practitioners, patients, consumers, compliance personnel, brand managers and packaging engineers, to name a few. Regulatory guidelines for products ensure the safe use of the product, including dispensing and administration. The label has to contain a lot of information for multiple users in a user-friendly manner by incorporating specific design, scientific content and other features in an accurate and readable way. Furthermore, the scope of labeling standards extends beyond the traditional packaging and include containers and cartons, in which the individual product packages are placed. These factors, along with others, makes the creation and maintenance of global labels a highly complex process as can be seen in the figure below.
Making a label is also a highly collaborative process that requires source data and expertise from multiple stakeholders. The journey of the label, normally, starts as a Company Core Data Sheet (CCDS) that is created with inputs from various departments and acts as the internal reference document for the label. Deriving a global label and its associated regional labels is further complicated by frequent changes in regulations and the need to comply with the regular updates. The number of stakeholders and the associated hand-offs in the highly labor-intensive and time-consuming process necessitates a more thoughtful approach. More than merely avoiding costly mistakes that creeps in during preparing plethora of documents, it is essential to proactively produce high quality global labels and adapt them quickly to various regions. Organizations must ensure that end-users obtain information of utmost integrity, both in content and form and product.
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