Quarantine at a Glance - Pharmaceutical Technology

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Quarantine at a Glance
A successful quarantine program requires collaboration among all departments of a pharmaceutical facility.


Pharmaceutical Technology
Volume 33, Issue 6

Quarantine database

To track the quarantine material, a database is essential. This tracking system should be designed to provide data inputs, queries, and reports associated with the discrepant material. The coordinator is responsible for entering the quarantine information within the tracking system.

The database is a key element in viewing the quarantine inventory. The database may include the following proper-

ties for each discrepant material: material description, batch number, quantity along with unit of measurement, the date the material was quarantined, and the reason why it was quarantined. The database should reference each record log number.

Management support

When developing a quarantine system within the company that wishes to engage in truly effective quarantine functions, support from the entire organization is absolutely necessary, especially from management. Without support from management, the quarantine program may not be effective and can end up with hit-or-miss results. Management should hold their direct reports accountable for ensuring the quarantine system is a reliable one.

Summary

The quarantine program should not be overlooked or given careless consideration. This program is also not a one-time event that involves one-way communication. It is a commitment between the organization's departments that should be treated as a partnership. Management should create a culture that promotes communication between the quarantine department and the entire organization to ensure control of nonconforming material.

Joanna Anglin is a quarantine coordinator at Talecris Biotheraeutics, 8368 US 70 Bus Hwy W, Clayton, NC 27520, tel. 929.359.4383, fax 919.359.4552, joanna.


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