Going beyond GMP – Assuring quality in the generic drug industry
For the pharmaceutical industry, the loss of revenue resulting from patent expiration – the so-called ‘patent cliff’ – has forced a shift in strategy, with pharmaceutical companies seeking to replace lost sales from drugs coming off patent by making changes to their business models.
Among the changes are: broadening product ranges or strengthening portfolios by acquiring generics producers; targeting emerging markets or areas of high growth in which patents have expired; as well as cutting costs associated with either developing innovative drugs or producing generics.
But for any of these shifts in strategy to succeed, pharmaceutical companies must be able to offer safe, effective products that are of high quality. By assuring the quality, safety and efficacy of drug products, companies can build reputation in markets and build trust with consumers.
This paper looks at how generic pharmaceutical companies can augment GMP processes with a QMS solution to establish a framework to build market reputation, build consumer trust and increase revenue.