Labeling-error recalls come in two varieties: wrong-label/bottle and label-content errors. The former, like Upsher-Smith's 3- vs. 10-mg Jantoven warfarin snafu, are often QA issues usually corrected through procedures-review and retraining.
However, content errors are often less straightforward. And for global pharma companies, even an error as seemingly trite as the repetition of a word (e.g., the double "not" behind J&J/McNeil's February Sudafed recall: "Do not not divide, crush, chew, or dissolve the tablet") can be a big red labeling-process flag.
Among the challenges in labeling operations for global pharma production is managing and eliminating redundant content, says Andy Glemser, principal at Glemser Technologies. Content naturally gets stored in many places in a global operation. "Processes may be global but implementations are national," says Glemser.
He spoke during a company webinar on challenges and recommendations for reusing and repurposing content for global labels. As such webinars go, this one included the soft company pitch for relevant product solutions. But Glemser also provided insight to global labeling challenges and some recommendations for complex content-management problems.
Adding to the problem of redundant content is change management, given differences in requirements among regulatory bodies across the globe, Glemser explained. One means for managing it all is use of a centralized, globally accessible content management system that can be distributed as needed. Glemser Technologies makes such a system.
On the recommendations side, Glemser advises managing labeling content in XML format and transforming the code as needed to meet country-specific submission requirements. Use an agency-neutral XML format to maximize reuse across submission standards. And manage content at the fragment level rather than the document level, using content place holders to share content across product clones, he advises.
- here's the release for yesterday's webinar
- and here's info on a global labeling solution for the EU's recently-discontinued PIM labeling standard