Continuous improvement concepts as a link between quality assurance and implementation of cleaner production: Case study in the generic pharmaceutical industry

TLDR

The study centers on process‑industry production systems, applying chemical‑engineering concepts rather than specific technologies. The study aims to establish the link between quality assurance and cleaner production in generic pharmaceuticals through continuous improvement. The authors apply Lean and Six Sigma tools, regulatory requirements, and quality standards to evaluate generic pharmaceutical production systems via two case studies, assessing continuous‑improvement impacts on quality and efficiency.

Abstract

The subject and the research objective presented in this article is establishing of the relationship between quality assurance and implementation of cleaner production in the generic pharmaceutical industry through the comprehensive concept of continuous improvement. This is mostly related to application of Lean and Six Sigma tools and techniques for process improvement and their link to other known concepts used in the industrial environment, especially manufacturing of generic pharmaceutical products from which two representative case studies were selected for comparative analysis, also considering relevant regulatory requirements in the field of quality management, as well as appropriate quality standards. Although the methodology discussed in this conceptual and practice oriented article is strongly related to chemical engineering, the focus is mainly on process industry, i.e. production systems, rather than any specific technological process itself. The scope of this research is an engineering approach to evaluation of the production systems in terms of continuous improvement concepts application, considering both quality aspects and efficiency of such systems.