Framework for continuous improvement
Abstract:
This chapter considers occasions that lead to the continuous improvement of manufacturing processes and programs in the life sciences industry, and to the revision of SOPs. Several groups of stakeholders in the sphere of FDA-regulated industry are identified. Each of these groups tends to be associated with particular kinds of observations, observations of various deviations from the anticipated manufacturing process and product. These observations initiate an investigation and revising process that varies in emphasis but that has an underlying logic. An observation is typically escalated, triaged, and can become the basis of an investigation and RCA. At the conclusion of the investigation, programmatic ...
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