Quarantine at a Glance - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology,
Click here