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Publication Detailed Description
A country perspective in exploring the links between hospital pharmacies and pharmaceutical industry: a case study application
Journal Title
Pharmaceutical Regulatory Affairs
Year (definitive publication)
2012
Language
English
Country
India
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Abstract
The pharmaceutical industry is one of the firms where the search for quality is very close to compliance. Yet a major paradigm change is occurring in this industry due to the increase of returns and recalls. Hence, in this paper the authors combine the findings of previous literature reviews with a case study approach. Findings from previous literature reviews emerged from the links explored between pharmaceutical drugs quality, reverse logistics and sustainability. With the addition of a case study on a global manufacturing corporation in the area of generic drugs products one step further is introduced: understanding the type of returns companies receive, in particular from hospital pharmacies. With this approach authors are creating a link between two different parties: the application of a quality by design (QbD) risk management approach with the reduction of variability and risk of noncompliance, through the increase of knowledge and value into their products and processes.
Acknowledgements
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