Wim Laurier, Chargé de cours
USL-B
" The pharmaceutical industry is confronted with many different issues at the levels of logistics and supply chain management. Traceability is a paramount in the pharmaceutical sector. It is not only essential to ensure the quality of the product, but also, it is required to trace possible adverse reactions back to a given lot of drug product, its manufacturing and control. Traceability needs to be addressed at three stages. First, the source (supplier) and origin (e.g. chemical, microbiological, animal, human…) of raw and starting materials must be identified. These materials must be tested and found compliant with compendial requirements. Second, traceability must be ensured in-house, throughout the all manufacturing process, from starting materials to the drug product, through the drug substance and all intermediates. Third, traceability should be ensured downstream, from lot release by the company to patient's administration. Traceability within the industry (stage 2) is...
