Ana Margarida Santos Bravo
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.
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Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report