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.
Highlights
This paper is motivated by the changes that the pharmaceutical industry is undergoing to cope with new challenges of the global economy
Towards the understanding of their major complaints, semistructure interviews were applied to the company in question, in the main injectable manufacturing and distribution sites, and to several hospital pharmacies in different countries of action. With this approach it is expected to link both parties in the application of a quality by design (QbD) risk management approach as well as reduce variability and risk of noncompliance
The goal of this paper was understand the reason behind the increase of pharmaceutical recalls, through a case study application
Summary
This paper is motivated by the changes that the pharmaceutical industry is undergoing to cope with new challenges of the global economy. The 2010 revenue was $731m; by region: 61% MENA, 28% from the US and for Europe and the rest of the world accounts for 10.9% Selecting it by segment, 23.9% are generics; 21.5% injectable drug products and 54% are branded. It is the second largest generic injectable supplier by volume in the US with combined market share of more than 15%. Towards the understanding of their major complaints, semistructure interviews were applied to the company in question, in the main injectable manufacturing and distribution sites, and to several hospital pharmacies in different countries of action With this approach it is expected to link both parties in the application of a quality by design (QbD) risk management approach as well as reduce variability and risk of noncompliance. With this approach a more sustainable pharmaceutical supply chain is expected to flourish, reducing waste, an increase of corporate social responsibility
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