Pharmaceutical companies are required to maintain full traceability upon the manufacturing of active ingredients and drug products. Traceability is required to ensure consumer safety, protect pharmaceutical products from fraud and counterfeiting, and improve production efficiency. Specific traceability and lot genealogy regulations have been established over time, including the US Drug Supply Chain Security Act.
To ensure compliance with regulations, Life Sciences Supply Chain Management allows users to print a report, including the full genealogy for a specific lot or container of material. The report is based on the standard Microsoft Dynamics 365 Finance & Supply Chain Management Item tracing functionality (Inventory management > Inquiries and reports > Tracking dimensions > Item tracing), and it can be printed by clicking the Print > Item tracing button once the tracing details are generated.
The information in the Item tracing form and the related report can be traced in different directions:
Backward – Trace downstream to identify the source of a manufactured product, the quantity that remains on-hand, and any production orders that are at least partially reported as finished.
Forward – Trace upstream to identify the destination. It is possible to retrieve the sales orders and the customers to whom the traced item or raw material has been (even partially) shipped.
The Item tracing report displays the trace criteria in the header and a line for each level of the material genealogy. The level value increases by going down in the genealogy, starting from 0 (inquired goods). For example, in the case of manufactured material, the level corresponds to the position of the ingredient in the BOM tree.
The Item tracing report can also be generated for batches linked to projects.