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even if the groups are not activated until a later date. The Project Manager, who is monitoring the project, must activate the groups at an appropriate time to ensure that adequate input is given on key manufacturing issues. In the meantime, the Project Manager must ensure a good flow of information to each group so it is fully prepared for the time when Manufacturing is fully involved. |
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Although the makeup of the groups is vital to high-quality input into the product development process and improving the flow of information within Manufacturing, the right process also needs to be put in place. Hence attention must be paid to the right level of objective setting, reporting on progress, and planning support. Clearly the project objective, personified in the target product profile, must reflect key manufacturing issues, especially where they set the parameters for the process. An example of this would be where a novel dosage form is needed to give a compound a competitive edge. Reporting must be done regularly to ensure that all key personnel in Manufacturing are informed of progress, not only at a senior management level, but also at an operational level where it is obvious that not everyone involved with a project can sit directly on the project team. Simple format reporting must be designed which minimizes bureaucracy and optimizes information. |
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Finally in planning, there are two basic options, decentralization and centralization. Decentralizing planning to set up a Manufacturing project planning system has some advantages of the plan being owned by Manufacturing itself. It also probably allows more detail to be put into the plan. However, in one sense this begins to reemphasize the separate nature of Manufacturing from the rest of the process. Centralizing planning has some advantages in that the key manufacturing milestones become an integral part of the overall development plan. Then it is still possible to do more detailed local planning to supplement the overall development plan. Using this approach also encourages central R & D planning to become more involved with the Manufacturing issues and hence help to support the Manufacturing Project Manager. |
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VIII.
Worldwide Production |
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As with all Functions in the modern pharmaceutical company, Manufacturing is a worldwide activity. Companies usually have a number of primary manufacturing units and certainly numerous secondary manufacturing units. Decisions about where to locate production are likely to be based |
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