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During this period of development, the secondary manufacturing process will be under full-scale investigation to establish |
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a reproducible process tailored to the likely scale of demand. This is obviously proportionately more complex where sterile or specialist manufacture is needed; |
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the pack requirements, the number of possible variants and the purchasing specification of the materials involved; |
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the supply chain logistics for products where, for example, shelf life or storage conditions may be critical; |
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the location of secondary manufacturing. Whereas in primary manufacturing the number of locations used may be relatively limited, the number of secondary factories may be quite numerous and a process must be defined which is qualified in each plant, even where the facilities are relatively less sophisticated than those in the company's principal plants. |
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The involvement of Secondary Manufacturing in these areas is now vital and has to deal with the technical and commercial issues related to worldwide supply. Once again there are issues during this phase that are time-critical for the overall submission. The choice of pack types, for example, and the setting up of the relevant stability studies to support the submission are critical. Although the number of options for most dosage forms is limited and relatively easily dealt with, new presentations or new materials may create more critical problems. A new inhaled product with a novel dosing arrangement may involve considerable pack development, engineering, and machine supplier support with long lead times. Hence, timing the involvement of Secondary Manufacturing, especially in a pack engineering sense, is crucial to ensure that what goes into the submission in pack specifications is supportable. |
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After the product launch, manufacturing issues continue to multiply to support the product roll-out worldwide. There are many factors to be considered relative to plant size and location. Plant capacity clearly has to relate to market size, which is often a moving target. In the initial phase of introduction, demand is relatively moderate and requires a small-scale production unit to service the demand. This requires setting up a nursery production unit to help initial market entry with the option of some expanded capacity as demand rises. In addition to providing market entry stock, such a facility is used extensively during formulation and process development to define and test the manufacturing method proposed. This provides stability test material and the extensive amounts of material required for phase |
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