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A successful quarantine program requires collaboration among all departments of a pharmaceutical facility.
Webster defines quarantine as "a period of enforced isolation." The word quarantine originates from the Italian word quaranti giorni, meaning "forty days," which is attributed to the 40-day isolation of ships and people entering into the port as a measure of disease prevention. Today, quarantine can be thought of as isolation that could be voluntary or compulsory. Quarantine periods can be very short. The purpose of quarantine is to contain the contamination such that others (e.g., animals, food, or product) are not put at risk. For the purpose of this article, "others" will be considered as pharmaceutical product.
Figure 1: Example of a quarantine label.
Within a pharmaceutical facility, the quarantine functions typically fall under quality operations. The primary purpose of the quarantine department is to segregate any discrepant material. One may ask, What is discrepant material? The answer lies within an organization's expectations. The organization should define and agree on what actually is discrepant material.
Procedures within the organization should define discrepant material and provide instructions for any necessary quarantine functions associated with the material. Other suggestions for quarantine procedures include responsibilities of each department that will be involved in the identification and segregation of the discrepant material. At a minimum, the procedure should outline the quarantine coordinator's responsibilities. The quarantine coordinator is responsible for maintaining documentation for material tracking as well as the input and removal from quarantine.
The quarantine program consists of four basic steps: notification, record preparation, segregation, and disposition. When developing a quarantine program, begin by identifying organizational expectations. If this task is a new program, employees may go through a learning curve and encounter several challenges.
One of the most critical elements of the quarantine program is communication. It is important that there is open
communication between the quarantine department and the organization. For the quarantine cycle to be successful, the following four steps should be followed.
Notification. The individual or department that identifies a discrepancy is responsible for notifying the coordinator of any needed quarantine activities. There are several methods of quarantine notification. This may include management requests such as an internal memo or a discrepancy tracking system. Another form of notification maybe as simple as a phone call to ensure timely action, then follow-up with official documented notification.
Record preparation. Quarantine records will summarize the material, batch number, weight or quantity, and the reason the material is quarantined. A sequential log number should be assigned to each quarantine record in order for accurate filing. Any documentation that supports the discrepant material (e.g., a quarantine notification) must be attached to the quarantine record.
Segregation. Quarantine material should be segregated and secured in a specific location, as it applies to the material type. The discrepant material may be moved to a separate area of the building or transferred to a separate building from the manufacturing process. The storage conditions should be considered when selecting the area where the product will be quarantined. Access to the segregated areas should not be permitted without the presence of the quarantine coordinator or designate.
Once the material is segregated, the container must be labeled with a quarantine label. The quarantine label should be printed on designated paper and attached to the discrepant material container. An example of a quarantine label is shown in Figure 1.
Disposition. The coordinator will release the material based on the manager's written request or the approval of a discrepancy investigation. The material could be dispositioned as "return to manufacturing" or "discard material." If the material is classified as "discard material," then appropriate documentation must be reviewed and/or approved before discarding. This documentation should be attached to the quarantine record. The quarantine coordinator or designate will remove any quarantine labels from the containers after material disposition.
Once the quarantine record is closed, records should be filed according to the log number in a separate area from the open quarantine records. Files should be in a localized controlled area.
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.
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.
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. firstname.lastname@example.org