Pharmaceutical Manufacturing and Health Information Technology: A Reflection About Lean Six Sigma and Industry 4.0

Pharmaceutical Manufacturing and Health Information Technology: A Reflection About Lean Six Sigma and Industry 4.0

Beatriz Maria Simões Ramos da Silva, Vicente Aguilar Nepomuceno de Oliveira, Jorge Magalhães
Copyright: © 2025 |Pages: 21
DOI: 10.4018/978-1-6684-7366-5.ch001
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Abstract

Pharmaceutical companies are seen as slow in adopting principles of operation excellence and advanced technologies. This article aims to explore the reasons why an industry, recognized as profitable and intensive in capital and science, is reluctant to implement emerging technologies and management tools capable of improving its operational performance. Operational excellence incorporates the fundamentals of Lean Six Sigma (LSS) methodology to the organizational culture and strategic management of companies. LSS is also known as the most used approach in continuous improvement programs in the industrial segment. Despite being a methodology used for many years, LSS continues to evolve, incorporating new trends such as data science technologies, which significantly maximize LSS results. Applying LSS integrated with I4.0 can generate essential information for the organization's decision makers through data identification, extraction, and analysis. In this sense, information technology is a strong ally of operational performance management in the pharmaceutical industry.
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Background

Almost two decades ago, the pharmaceutical industry began to face a series of adversities: declining productivity in Research & Development; increasing regulatory requirements; novel and more complex therapies, such as personalized medicine; increasing competition and complexity; pressure to reduce drug prices and more recently, a high number of recalls and shortages due to quality problems (Yu & Kopcha, 2017). Additionally, it was found that the performance of production processes was inferior to that of other types of industry, presenting high variability and consequently large fluctuations in cycle times; high scrap and rework rates and elevated quality costs. These challenges imposed the need to make manufacturing more agile, flexible and efficient, without increasing costs. It was necessary for the pharmaceutical industries to adopt operational excellence and continuous improvement programs, implemented long before in other industrial segments (Basu, 2010).

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