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project and communication/coordination, a good technical support structure is also needed to ensure that the process is designed with manufacturing capabilities and any technical constraints in mind. |
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Two product transfer groups are needed to deal with the actual technical development of the process and its transfer into the primary and secondary manufacturing unit (see Fig. 2). Although they deal with different parts of the process it is important that they communicate well between them. Hence some common membership is advantageous, as well as some joint meetings where issues of interfaces between the teams are handled. The central Project Manager is a member of both teams and indeed probably acts as chairman of both for the main meetings. |
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The primary process handover team has two main objectives which cover numerous subissues: |
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to produce a safe, reproducible process which can be transferred to a number of plants around the world at a suitable cost of goods; the safety issue is crucial because, with increasing environmental protection legislation around the world, this issue has to be dealt with during the development process; and |
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to ensure that the dossier reflects the needs of primary manufacturing in terms of achievable specifications. |
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To achieve this, representation is needed from the Chemical and Analytical Development in R & D, primary plant management in Manufacturing, QA, Engineering, Environmental/Safety management and Purchasing. The central manufacturing Project Manager acts as the coordinator for the group to ensure that it understands the demands on the process, the priority of the project, and the overall plan being pursued by the R & D project team. |
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The secondary group is somewhat larger because it has to deal with many more issues and may indeed need to split into different subgroups if different dosage forms are needed. However, a core team is needed to coordinate all the detail of the program to ensure that it remains integrated across the full development. The composition of the secondary group obviously varies somewhat depending on the formulation, but comprises Secondary Manufacturing (e.g., tableting, sterile products), Packaging (the relevant packing unit), Pack design/engineering, Purchasing, Engineering and QA. Once again the Project Manager acts as the chair/coordinator of the group. |
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When should each group be formed? It is important that the structure and membership is in place as early as possible in the product's life cycle, |
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