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market. If OTC launch is contemplated, cost is also an important factor because price to the consumer is much more critical than if the molecule is a prescription product. |
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The key issues facing Manufacturing as a result of recent changes relate to their influence on the process of development and the degree of their involvement. Both primary and secondary Manufacturing need to be involved in numerous stages of the development of a product. The question is how should that involvement be triggered and by whom? There is a need for a well defined management process covering technical and commercial issues. This must interlock with the central R & D project structure and reflect the need for manufacturing project management and technical support structures. The purely physical operation of production is only one aspect of the activity. With pharmaceutical products, there are high risks and high rewards, and the triggering of actions in R & D, Marketing, and Manufacturing must be carefully considered before initiation. The balancing of expenditure against time and the risk of drug development is a crucial central role that must take place in Manufacturing as in all other units involved in development. To ensure that strategic decisions on investment timing and critical actions are well controlled, a business function is needed in Manufacturing, working alongside the production areas, to initiate relevant discussions and actions. |
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II.
Manufacturing Philosophy. |
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To meet the demands now placed on it, Manufacturing must alter the traditional stance frequency adopted toward involvement in product development. In addition, R & D also has to offer the optimum opportunity to involve Manufacturing in the process so as to achieve the best overall results for the organization. In the recent past a good deal of mutual suspicion existed between R & D and Manufacturing over the development process because of conflicting corporate objectives. For example, take the need for R & D process scale-up work in the manufacturing plant. This is not generally included in output figures for Manufacturing, hence reduces overall efficiency, and has often led to restricted access to the plant. R & D looked on Manufacturing as a secondary issue during development and has not tried to optimize production of the product, dealing instead with essentially scientific/medical issues as a priority for the dossier. Although this is quite correct from a restricted view, it misses the opportunity for close collaboration and improvements to launch with a right first-time dossier and right first-time process. Increasingly it is recognized that the key target |
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