By Jim Miller, President, PharmSource
Forecasting is central to manufacturing operations and supply chain management. It drives scheduling, raw material ordering, inventory levels and many other decisions that ensure an uninterrupted market supply of finished product.
However, forecasting really doesn’t work very well when planning the manufacturing requirements for new product launches. It has to be done so far ahead, and take into account so many variables, that it is often wrong – at great cost in lost revenues or misspent capital expenditures.
Manufacturing and supply chain planning must begin four to five years before actual product launch, maybe even longer if the manufacturer makes Phase 3 clinical trial materials. If manufacturing is to be done in-house, engineering studies and plans must be completed, facilities built or modified and equipment ordered, installed, and qualified. If production is to be outsourced, CMOs need to be identified, contracts negotiated, and, if special capabilities are required, the CMO must examine its engineering and capital investment program.