With one of the most challenging and stringent regulatory environments of any industry, Life Sciences manufacturing requires meticulous adherence to quality standards and process controls.
On top of operating within the boundaries imposed by this regulatory environment, the life sciences market should also proactively aim to satisfy customer demand. However, maintaining inventories at high levels in an industry where expiration dates are a strong constraint should not be viewed as the right answer. Very often, companies face logistical issues, such as complex distribution networks regulated by different legislative regimes, resulting in very high costs. But extreme fragmentation in the networks of manufacturing facilities, sales offices, distribution warehouses and suppliers, as well as the number of different actors in the supply chain, must not lead to an inability to react.
The extremely restrictive dynamics in production (traceability, batches, deadlines, contamination) and sequencing optimization rules require companies to be extremely flexible in production operations as well: management of API, primary and secondary packaging require continuous and consistent processes and optimization.
