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.Quarantine approach
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.