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Model traditional manufacturing

FDA has recently indicated that FDA s traditional model of manufacturing site inspections and border examinations is simply not adequate in today s transformed world (Mullin, 2011). There is a general understanding that when companies outsource a function(s) to a CRO/CMO that these organisations in turn, become subject to the same regulatory responsibilities and scrutiny as their clients, i.e. control of the product s quality has to be maintained (Linna et al., 2008). [Pg.16]

This does not follow the traditional models outlined in Good Manufacturing Practice (GMP) guidelines such as GAMP, but this is acceptable so long as the... [Pg.172]

In the framework of FDL, the manufacturing systems are modeled by computer information and graphics. Various information teams are included in the model that are not seen in traditional models (Witzerman and Nof 1995) ... [Pg.171]

Part modeling is the historical area of computer aided design, drafting, and manufacturing. Traditionally, part models were constructed individually and each part model was stored in a separate file. Now, five different aspects integrate part modeling in a comprehensive product modeling environment. They are ... [Pg.285]

The quotation above emanates from the U.S. auto industry and illustrates the stresses and approaches to dealing with them in this competitive industry. The complainer, the CEO of a U.S. fastener manufacturer, was contrasting American auto manufacturers to Honda. The conclusion to draw is that the way trading partners work together varies widely. The spectrum ranges from downright hostile, arm s-length confrontation to extensive collaboration on multiple fronts to produce win-win results for both sides. Most follow the traditional model described below. [Pg.207]

Traditional industry paradigm has the Quality Department responsible for quality and the Manufacturing Department responsible for producing product. Inherent conflict exists in this model due to competing functional priorities. By building quality concepts and accountabilities into production processes responsible for production, quality becomes infused into the organization. Both Quality and... [Pg.245]

The reaction system involved in the case studied is a kind of relatively complex van de vusse reaction, nevertheless the reaction system in real manufacturing process may involve more reaction types and, therefore, is more complex than that one. One can, however, simulate the change of environmental indexes within a reactor by combining traditional reactor mathematical model with the PEI balance, and may also discover the effects of reaction conditions and engineering factors on environmental performance by PEI rate-law expression and/or combinations it with other reaction rate equations as well as other related equations in reactor mathematical models. [Pg.21]

For several decades, instrument manufacturers have made process instruments by placing the bench instrument they are selling in an explosion-proof casing. Often these were simply the same components as in their laboratory models, merely dissembled and put into industrial casings. A number of non-traditional manufacturers are beginning to design and produce components using the triple credo of smaller, faster, cheaper. Some of these components are described herein. [Pg.32]


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