Issues and problems for the biopharmaceutical industry that make the situation challenging
Abstract:
This chapter deals with the various issues which make the implementation of Lean strategy to pharmaceutical systems more of a challenge than from mainstream production line manufacturing, for example as one sees in the auto industry. There is a detailed discussion about the role of the regulatory compliance process and its impact on Lean implementation in pharmaceutical systems as well as a review of the complexity of the differing unit operations which makes streamlined leveled flow less than straightforward.
Key words
regulatory process
consent decree
warning letter
integration
upstream/downstream
compliance issues
layout hybrid systems ...
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