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FDA audits: Maintaining a constant state of readiness

The Food and Drug Administration audits Anderson Packaging's operations annually. So do the contract packager's customers. Facing these annual audits of its facilities and procedures, Anderson Packaging follows the following quality-control steps to win auditors' approval: • Sophisticated vision systems check pills, capsules, and liquids to ensure that product units are not broken and that they are placed properly in each package. Such equipment is extensively validated prior to start-up and continuously challenged to maintain its integrity. Each package component is barcode-scanned to confirm accuracy. • A full-time staff trains new workers in pharma product and packaging basics, and then develops their skills to more advanced levels. Training is documented and made available to external auditors. • Anderson has strict requirements on the inspection of packaging components as they arrive at its facilities. Typically on the inspector's checklist: package integrity, print quality and correctness, and chemical properties. • Quality-control inspectors check the quality of finished packages, both in-process and after a packaging run.

--By Jim George, Editor, Contract Packaging magazine
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