Inventory Hold, Lookback and Traceability
- Inventory Hold, Lookback and Traceability
While a plasma sample is being tested, the unit is held in inventory for a specified period of time at one of our state-of-the-art Plasma Logistics Centers before it is released for manufacturing. Inventory hold minimizes the chance of viruses entering the plasma pool by allowing us to discard specific units should a donor subsequently test positive for a viral marker during the holding period. Only units of plasma from repeat donors who are qualified as suitable to donate are used in manufacturing. In this way, PLCs make sure that only units that meet all our stringent specifications are ever sent to manufacturing sites.
Inventory hold is part of a voluntary industry initiative and allows for the retrieval of any suspect donations before they are considered for use in producing plasma-derived medicines. Plasma from each donation and each donor can be traced to specific lot numbers through the Donor Management System (DMS), an integrated computer network. Traceability ensures plasma quality and safety. Both testing and inventory hold ensure that only the highest quality plasma is used in production.
If any potential problems are identified during this period, the plasma is rejected. If, in the future, new information becomes available regarding a donor’s health status, previous donations from that individual can be traced and destroyed prior to pooling for fractionation via a lookback process. This process helps ensure that only the highest quality plasma is used in producing plasma-derived medicines.
In addition to our own operations, CSL Plasma partners closely with the blood banking communities of the United States and Europe in order to use plasma that is recovered from donations of whole blood. This plasma is subject to all the blood banking safety systems and is fully integrated into CSL Plasma’s logistics and information systems.