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upon slightly differing considerations for the drug substance and the secondary pack. For the drug substance, the decision is as much financial as anything else. Tax breaks, low-cost manufacturing areas, etc. all play a part in determining the most appropriate location for the primary manufacturing site. For secondary production, the decision is slightly more complex and certainly involves a good deal of consideration of logistical, technical, and financial issues (especially transfer pricing and retained local profits). Tablet manufacturing and sterile production are concentrated in a few areas because of the technical issues that they raise and the high cost of such facilities. Packaging is much easier to transfer to a local market where some financial incentives are offered for locating at least part of the manufacturing in a given country. |
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Given the worldwide nature of manufacturing, it is important that a structure similar to the one described above is installed in all countries where products are to be introduced. The central Project Management team still acts in a strategic role to keep a tight control on the timing of introduction, but local teams are needed to ensure a smooth transfer into the local facility. The central product transfer group members assist in this process by ensuring that local staff is aware of particular technical issues that arose during development. |
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With increasing the complexity of the drug development process and with pressure on time and cost, a more holistic approach is needed to involve all functions and ensure that outcomes are optimized. Manufacturing must take a central role, along with R&D and Marketing, within the whole product development process. To do this, it must structure itself to optimize both technical and commercial input into crucial development decisions. Using a Project Management Group approach to act as a central coordinating body within Manufacturing, therefore, is recommended to ensure that technical involvement is orchestrated at the right time and business-related decisions are taken in the light of cost, risk, and time factors. |
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T Hill, The Strategy Management of the Manufacturing Function, Manufacturing Strategy. Macmillan Press Ltd, 1992, pxy. |
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S Wheelwright, K Clark. Quantum Leaps in Speed, Efficiency and Quality, Revolutionising Product Development. Free Press, 1992, PXY. |
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