Material Traceability in Continuous Pharmaceutical Tablet Manufacturing

Continuous manufacturing has the potential for a higher level of quality control than batch manufacturing. Because the process is different from traditional batch operations, however, regulatory requirements, such as traceability, will be achieved in a different way. Defining a batch and lot The Code of Federal Regulations Title 21 presents the following definitions (17): * Batch: "specific quantity of a drug... intended to have uniform character and quality, . produced according to single manufacturing order" * Lot: "specific identified portion of a batch, having uniform character and quality, . in the case of ... continuous process, it is a specific identified amount produced . that assures its having uniform character and quality . " * Lot number: "distinctive combination of letters, numbers, or symbols, or any combination of them, from which complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product ... can be determined." For material traceability purposes, however, the tablets containing raw material from one batch and another need to be distinguished. Because this raw material batch change occurs during a single manufacturing order, with no changes to the process conditions, it is, therefore, still the same batch of finished drug product. The tablets created between these two times will have a mixture of the component's previous batch and new batch and will be referred to as a "transitional lot." Because the goal for material traceability is to trace component batch numbers for each lot of tablets, the authors propose assigning a new lot number every time the effect of a component batch change is predicted to affect the tablets at the outlet, whether that be the new batch being present in the tablets, or the old batch no longer being present in the tablets.