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Su (1994) cautioned that superficial attempt to reorganize plant layout not matched by accompanying changes to manufacturing processes may lead to JIT failure.
The use of process analytical technology can help support the understanding and reduce the risks associated with changes to manufacturing parameters, equipment, or sites.
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They are taking on this sum of money so early because they believe it is a huge market and if they can attract the right talent, they can bring a substantive change to manufacturing that is lacking today.
At that time, a new product could receive regulatory approval without undergoing clinical trials if it could be classified as a "change to manufacturing method having no effect on the effective ingredients" [ 13].
Firstly, internal cycles during the innovation process itself going from engineering change cycles, to manufacturing resource cycles or even team building processes.
Differences between a biosimilar and its reference product may also emerge over time due to manufacturing changes [ 6].
Robust pharmacovigilance to track and accurately attribute adverse events (AEs) is important for all biologics after approval because their complexity and sensitivity to manufacturing changes make them susceptible to structural alterations that can affect safety (e.g., immunogenicity) 7, 26.
Biopharmaceuticals require multifaceted manufacturing and purification processes, and changes to the manufacturing process can result in differences in quality, safety, and efficacy (ie, 'the process is the product').
ODMs (original design manufacturers) in Taiwan are incredibly deft at making quick changes to their manufacturing runs.
In Mexico, Wal-Mart brought "massive changes to the manufacturing sector," Mr. Ryba said.
This situation limits the reuse of ready-made components and requires physical changes to the manufacturing system.
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