While the pharmaceutical label may appear to be a small part of the drug delivery system, it is this packaging detail that manufacturers frequently fumble, forcing them to recall inaccurate labeling and package inserts, either by FDA mandate or as a preemptive measure to avoid liability. And on closer inspection, it’s easy to understand why these recalls occur.
Proofing pharmaceutical labels is tedious, repetitive work. Pharmaceutical labeling stakeholders from marketing, legal, operations, and regulatory perform a series of tasks that are mired in minutiae and far removed from other strategic focuses such as quarterly earnings, brand engagement, sales forecasts, and stock price. They are instead charged with reviewing label and artwork content, often across hundreds of product and packaging versions, and held responsible for identifying errors such as:
- Inaccurate colors or color separation
- Electronic file distortion
- Incorrect fonts
- Codes that don’t read perfectly
- The same code numbers on different components
- Misspelled text
- Wrong product name or strength
- Font sizes that don’t comply with regulatory agency requirements
- Incorrect translations on foreign language artwork
- Exclusion of country specific information
- And more!
A key ingredient in this proofing exercise is text comparison between files, sometimes in different file formats such as Word/PDF and in different layouts such as manuscript/artwork. This is somewhat akin to the game “spot the differences” we all played as kids, where you spot the differences between two images… but with much harder rules:
- The players don’t know ahead of time how many differences there are.
- The players have to review the same document multiple times.
- The players are comparing complex, multi-page documents.
- The text is usually in different layouts.
- The font is often different.
- The players can easily spend 40 minutes on each comparison.
- The text is frequently written with nine point font size or smaller.
The good news: there’s a way to cheat! Using Online Proofing technology with a text compare tool can save time and effort when proofing pharmaceutical labels and artwork, and many text compare tools have an extended set of features and functionality. For example:
- Copy validation is automated and reliable, systematizing tedious, time-consuming activities to catch errors early and avoid costly mistakes.
- Users can compare artwork and copy documents in multiple formats (PDF, Adobe Illustrator, Word, Excel) with just a couple of clicks, even when the layout or text flow is not the same.
- Complex tables, even when formatted differently, will produce accurate results, regardless of language or character set.
- Users can generate comparison reports that comply with regulatory requirements and can be accessed both from macs and PCs.
- A full audit trail ensures quality standards are met, such as 21 CFR Part 11, and all documents are securely stored in a database to ensure integrity.
Pharmaceutical Labeling: A Strategic Process
Across the pharmaceutical industry landscape, labeling is increasingly identified as a mission-critical process that advances an organization’s strategic goals – as much as quarterly earnings, brand engagement, sales forecasts, and stock price do. Forward-thinking global pharmaceutical companies view labeling from this strategic perspective and implement Online Proofing technology with a text compare tool to meet exacting regulatory standards and avoid expensive recalls, ultimately protecting their brand reputation and driving business growth.
To learn more about improving your pharmaceutical labeling design processes, download our e-book: Advanced Labeling and Workflow Solutions for the Pharma Industry.