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| Manufacturing Involvement by Phase |
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| Stage of development | | Role of manufacturing group |
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Molecule selection |
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Maintain awareness, monitoring, evaluating implications |
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Central Manufacturing Project management group |
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New processes, formulations, long term plant and machinery, implications of new technology uses |
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| Preclinical Phase I/II | |
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Active involvement in primary process development |
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Monitoring secondary issues |
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Central Project Management, primary development team |
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Least-cost process, make or buy decision, plant, location of production |
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| Phase II/III | |
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Further refinement of primary process, full secondary development |
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Central Project Management, primary and secondary development teams |
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Final stages of primary process, secondary pack and process development (Market entry) Planning |
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Phase IV/launch |
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Commence introduction of formulation and pack variants; full support to the market |
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Central Project Management Secondary development team |
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New formulations introduced, new pack designs |
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Improving capacity management |
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Full commercialization |
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Patent expiry | | |
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Central Project Management |
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Process patents, monographed specs |
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New innovative formulations and pack designs |
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