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9 Tips to Prep for Labeling Inspections

Live from Pharma Packaging and Labeling East Coast 2019, a global labeling management head offers important considerations, from canned presentations to the pros and cons of pre-inspection requests.

Roya Behbahani, Director and Labeling Cluster Head in Global Labeling Management at Pfizer, presenting at the 11th Pharma Packaging and Labeling East Coast 2019 in Philadelphia.
Roya Behbahani, Director and Labeling Cluster Head in Global Labeling Management at Pfizer, presenting at the 11th Pharma Packaging and Labeling East Coast 2019 in Philadelphia.

While critical topics such as manufacturing process control garner much attention during inspections, artwork and labeling account for a fair share of findings during inspections.

This scrutiny has led many companies to adopt end-to-end tracking mechanisms to deal with inspections, which has caused a downward trend in observations on these topics in recent years, according to Roya Behbahani, Director and Labeling Cluster Head in Global Labeling Management at Pfizer.

Behbahani instructed attendees at the 11th Pharma Packaging and Labeling East Coast in Philadelphia that preparation is key and offered some interesting insights in deciding how to prepare.

1. Preparation should be a way of working versus suddenly preparing when inspectors are on their way. What does this mean in practice? “What we emphasize at Pfizer is making sure that the data we put into a tracking system makes sense,” Behbahani said. Maybe the data input seems clear right now, when you’re involved in a given project or task. But will it make sense in two years? It should become habit to enter data that is clear and explanatory, so that it still makes sense after some time has elapsed.

Pfizer maintains ongoing monitoring—the “labeling police”—that check that the data entered makes sense. “It makes things a lot easier. Everything is looked at throughout the year,” she said.

This also means having some canned presentations that explain processes—including overview material—that you know auditors will ask about. She noted, “Present these holistically, not just for a small part of the process. Make it make sense for the inspector.”

2. Identify global and local colleagues. As Behbahani explained, “Local can mean global. Health authorities talk to each other. If one of them finds something critical, you can be sure they’ll share it with others.”

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