• FDA inspections at the CP are usually job-dependent and typically occur "if the FDA sees our name pop up on a manufacturer's NDA [New Drug Application], where the company filing for the drug has to submit all of its regulatory documents and list the sites where the tablets are manufactured and where the packaging is done." When an FDA auditor visits an Anderson Packaging facility, he or she "reviews our processes, our equipment, our facilities, and our documentation," he says. "We are fully inspected in the packaging area just as stringently as the customer would be if they were doing it themselves."
• How does the CP prepare for an FDA audit? "You really just can't let up," states Schroeder. "You have to operate on a daily basis under the anticipation that the FDA could show up. All our documentation has to be kept accurate up to the minute. We have batch records, which are all the instructions and sampling requirements for any given lot. We have to have a document that says how we're going to do the job, how many samples we're going to take, and how frequently we're going to take those samples. Samples are for quality checks, making sure they meet all the quality standards that we've established with the customer."
• What is the FDA looking for? "Repeatability is important to the FDA," he says. "It's the package integrity. Drugs are a serious issue. You want to make sure you deliver a consistent package. The FDA wants to make sure that we have documents that clearly spell out that we've established a repeatable process. Those processes could include dwell times, heat parameters, and the speed at which a line is going to run. We have to validate all those processes and we have to keep documentation that proves that we've done that."
• What does this mean for pharma packaging customers, and how do you work with the FDA? "Each customer that we're proposing to do packaging for wants to see our FDA reviews. After a review is done, the FDA will actually publish a report for you. It calls out any observations that they had, good or bad. If there's any action items that need to be addressed, we work with the FDA to take care of them. You always want to have a good relationship with the FDA."
• What are the trends when it comes to packaging machine technology? "Staying ahead of the technology curve is a major issue, particularly with inspection and vision systems," Schroeder notes. "Vision systems are becoming more sophisticated. They can detect whether a tablet is 25- or 50-percent broken. We have to verify that we have the correct product in the correct cavity, especially when we run products that have different strengths or types of drugs within the same package."
Anderson Packaging, Inc. serves pharmaceutical and healthcare packaging customers from seven facilities, including a new 148,000-sq-ft plant in its headquarters city, Rockford, IL. It packages pouches for oral solids and powders, as well as for carded blisters, fills vials and bottles, and employs thermoform/fill/seal, horizontal and vertical form/fill/seal, cartoning, and secondary packaging equipment.
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--By Jim Butschli, Editor