Labelling and Generics: Who Is Accountable?

Manufacturing Chemist
June 2016
Author: Bindu Narang, Sciformix Corporation

Product labelling is a collaborative process, from initiation of a clinical trial to commercialisation, with multiple sources of inputs that result in a company core data sheet (CCDS). The CCDS includes the minimum safety relevant information that needs to be present on the product labels and any local labelling information for different geographies are derived from this.2

Every local labelling document (LL) devised from the CCDS could be different, depending on the geographic regions and on the product formulations. Complexity increases when these local labelling documents are in a different language, with differing content. These local adaptations also need to be updated whenever there is a change in the CCDS due to availability of new safety, efficacy or product quality information and changes in regulatory landscape.

Changing regulatory requirements and the numerous hand-offs make the process more complex. The existing process of developing a product label is human resource-intensive, and, therefore, requires extensive reviews and proofreading to ensure that the printed label is error-free. All of these factors add significantly to cost and time, not to mention being fraught with the possibility of introducing manual errors.

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