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Pharmaceutical Development and Life Cycle

The case for Lean Six Sigma in pharmaceutical formulation and process development

The evolution of the pharmaceutical industry has made product formulation, process development, and life cycle management more critical than ever. Expiring patents and the rise of generics, in addition to increasing drug development costs and regulatory requirements, are forcing pharmaceutical companies to develop products faster, cheaper, and better compared with just a few years ago.
Formulation and process development is one of the key—and at the same time most difficult and costly—segments in product development and commercialization. It is also one of the most critical functions, in which the future of a product, its potential success, the level of quality risks, and the strength of its patents, manufacturing capabilities, and customer satisfaction are determined.
For the development of products with good formulation and manufacturing processes in the least time possible at reasonable costs, the trial-and-error approach isn’t the best one—but shortcuts should be avoided. Indeed, the process of product development requires a systematic approach that ensures that only the right steps are taken, and in the most logical sequence.
With the increasingly competitive landscape of the industry, rapid and significant productivity improvements are becoming a prerequisite for every pharmaceutical company’s survival. Six Sigma tools and techniques, used in conjunction with methodologies common to Lean practice, have fostered a powerful performance system that has enabled noticeable productivity growth in other industries over the past few years. Indeed, Lean Six Sigma provides the basis for the strong complementary relationship that is shared by process, quality, and performance, a relationship that leads to sustainable competitive advantages.

via niazi-pharmaceuticalinfo.blogspot.com

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