Quality Vision

These requirements impose a special set of constraints on pharmaceutical packagers, explains Director of Quality Dick Leach, noting that raw material management and effective change control are built into Nosco's approach to quality.

"Customers are creatures of habit and don't want anything to change," he said. "Because customers value consistency and want to avoid issues with their drug components, having a quality system that ensures a consistent source of supply, compliance with material specifications, and material traceability are absolute requirements. In the commercial markets, by contrast, you have a little more flexibility to change your material suppliers job by job to drive costs down. In the pharmaceutical market, it's somewhat different; customers want you make sure you're continuously running the same raw materials, the same inks, the same systems—everything—to ensure the integrity and consistency of the run. By the same token, if you have to change a component for any reason, customers want to be brought into the loop to acknowledge and approve the change by adding it to the specifications or otherwise documenting it."