NEWS & EVENTS: PDA Audit Program Under Discussion


The Parenteral Drug Association (PDA; Bethesda, MD) might set up a centralized packaging-supplier audit program that would allow pharmaceutical companies to see details of an audit and accept its conclusions without having to visit the facility.

Consultant George J. Grigonis Jr. (Feasterville, PA) coordinated and developed such a program for PDA regarding computer technology suppliers, and the association has asked him to branch out to other areas, potentially including packaging. He presented the idea to PDA's Packaging Science Interest Group at the association's annual meeting, held December 4 in Washington, DC.

The program would provide a common process and common tools for auditing and save pharmaceutical firms time and money by allowing them to reference previous audits of a supplier rather than send their own people out to do another one, Grigonis said. FDA accepts third-party audits, though some drug companies are still uneasy about using them, preferring to handle all supplier relations themselves, he noted.

PDA would train and certify anyone who wants to be an auditor for the program. The audit would employ a standard guide and questionnaire but allow the auditor to go into detail, and audit reports would not be accepted unless all comments were nonjudgmental, Grigonis said. Auditor certificates would be renewed every year, so if the audits are not performed correctly, the auditor could be removed from the program or sent back for more training.

Participating drug companies would receive a notice whenever a particular supplier was audited under the program, and when the results of that audit would become available. The program would also alert participants when an audit was two years old, indicating that it might be time for a new one. Suppliers could request audits through the program, or a drug company could sponsor an audit. The party who requested or sponsored an audit would pay for it.

The association hopes to convene a task force of packaging-related personnel to develop a curriculum for the training program and metrics for the audits.

Erik Swain

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