How Pharmaceutical Manufacturers Can Ease Labeling System Validation
by Susan Gosnell, on October 1, 2021
Imagine investing fifteen years or more in developing a promising new drug, only to have a simple labeling error derail your launch plans, or – even worse – result in a product being quarantined or recalled from the market. Unfortunately, this is not at all uncommon. FDA drug recalls are on the rise, increasing 65% over the last decade (Source: GS1), with half caused by errors in the product labeling or packaging artwork (Source: XTalks). These labeling recalls can be a nightmare for pharmaceutical companies, costing millions of dollars to correct the non-compliant labels and rework associated product packaging.
Sure, quality control is difficult, but it also has its advantages
Most labeling errors can be avoided by improving process and document control protocols, but savvy pharmaceutical companies are going a step further and investing in enterprise solutions that simplify label management. These software-based solutions reduce risk, ensure regulatory compliance, and maintain detailed records of label and barcode changes while providing centralized, cloud-based storage of labels, barcodes, templates, and production reports.
Implementing an Enterprise Labeling solution can also help pharma companies remain competitive in a landscape rife with ever-changing regulatory, governmental, and market challenges. Digitizing the entire label and barcode creation, modification, and storage process allows manufacturers to produce compliant labels while reducing costs and becoming more efficient. But Enterprise Labeling solutions require intensive software validation, and too many companies try to offset the expense by employing outmoded testing processes to demonstrate that the new system is performing to specification.
Tackling validation in the most efficient way
This penny-wise but pound-foolish option mentioned above is perhaps not the best choice for so critical and daunting a task.
The documentation alone can take even the most focused validation team weeks to complete, and the sheer volume of testing to qualify a new labeling system can introduce time consuming cycles for smaller manufacturers without the wherewithal to handle the complexity that comes with validation.
Sometimes, even determining what testing needs to be done to validate a new labeling system can be a challenge, as the regulatory mandates are not always clear, leaving it to the pharmaceutical manufacturer to navigate the process. What’s more, crafting a compliant validation plan is not easy and can take even the most knowledgeable regulatory team many long hours to complete. The installation, operation, and performance qualification protocols alone are intensely detailed documents and processes that can commandeer resources for weeks if not months, taking staff away from other tasks and further extending the time to go live.
Time is money in the pharmaceutical industry, and complex, lengthy validation processes are not conducive to market success. A validation acceleration pack (VAP) can simplify validation by offering a standardized set of fully customizable templates to guide the user through the process to a fully compliant system. The templates can be adapted to meet the needs of each project, facilitating ongoing compliance with FDA and EU standards, and reducing future audit stress.
Loftware is a provider of cloud-based Enterprise Labeling solutions for the life science industries. Our VAP enables the quick and cost-effective validation of a labeling system in order to ensure compliance and increase productivity while minimizing validation IT burden and costs. The templates facilitate the path to a compliant commercial off the shelf Enterprise Labeling system. For more information, download the VAP specification sheet or contact Loftware to discuss your validation project.