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Outsourcing reasons

The roots of the big and medium pharma companies go back either to drugstores or chemical companies, the former prevailing in United States the latter, in European enterprises. The lack of a chemical manufacturing history is also a reason why US pharma companies en principe are more prone to outsourcing. [Pg.95]

A laboratory may outsource aspects of its work occasionally because of unforeseen reasons (too great a workload, equipment problems, need for outside expertise) or on a regular basis. Where work is subcontracted, a competent laboratory (i.e., one that complies with the standard), must be used. The customer must be notified in writing about the use of subcontractors, and a register of all subcontractors, including calibration services, must be maintained. [Pg.271]

Many pharmaceutical companies outsource one or more of the control, manufacturing, and chemistry (CMC) processes, for which numerous regulatory agencies guidelines are available. Reasons for this outsourcing include but are not limited to ... [Pg.2501]

The globalization of pharmaceutical companies means that, within the same company, the same assay may be carried out at different sites, within the same country or in a different continent. Under these circumstances, it needs to be assured that the assay transferred to each of these sites continues to perform as originally developed and validated. In addition to within-company transfers, there is an increasing tendency to outsource methods to contract research organizations (CROs). The method is usually developed within the innovator company and subsequently transferred to the CRO. The reasons for using CROs vary with the philosophy of the company. [Pg.265]


See other pages where Outsourcing reasons is mentioned: [Pg.7]    [Pg.15]    [Pg.420]    [Pg.327]    [Pg.8]    [Pg.20]    [Pg.83]    [Pg.178]    [Pg.45]    [Pg.227]    [Pg.122]    [Pg.24]    [Pg.409]    [Pg.280]    [Pg.335]    [Pg.360]    [Pg.89]    [Pg.669]    [Pg.440]    [Pg.190]    [Pg.861]    [Pg.101]    [Pg.2488]    [Pg.418]    [Pg.917]    [Pg.120]    [Pg.350]    [Pg.490]    [Pg.2018]    [Pg.51]    [Pg.71]    [Pg.737]    [Pg.34]    [Pg.67]    [Pg.78]    [Pg.245]    [Pg.475]    [Pg.176]    [Pg.909]    [Pg.219]    [Pg.1888]    [Pg.11]    [Pg.307]    [Pg.2225]    [Pg.292]    [Pg.57]   
See also in sourсe #XX -- [ Pg.89 ]




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Outsourcing

Reasons to Outsource

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