ABSTRACT

The pharmaceutical industry is one of the most regulated in the healthcare industry, specializing in the discovery, development, and manufacturing of novel, life-saving medications. However, it has its own set of difficulties as it navigates stringent laws, sophisticated production procedures, and its aim of constant development. With rising competitive markets, the pharmaceutical industries are embracing process improvement strategies to stay competitive in their sectors. Among these strategies, Six Sigma has emerged as a promising and evolutionary method adapted by the pharmaceutical industry to improve pharmaceutical quality and reduce defects. Six Sigma is based on a combination of the principles of quality assurance, and quality control by analysing the data. The Six Sigma methodologies DMADV and DMAIC have become increasingly essential within the pharmaceutical industry because of their capacity to attain a precision level of 99.997%, demonstrating their significance in ensuring high accuracy and efficiency in operations. This review explores the implementation of Six Sigma for continuous improvement in the pharmaceutical sector and the future implication of Six Sigma in regulatory affairs, highlighting its importance in ensuring compliance with changing regulations, enhancing regulatory submission, and driving continuous improvement in the regulatory landscape. Keywords: Pharmaceutical sector, continuous improvement, Six sigma, DMADV, DMAIC, Regulatory
Publication date: 01/05/2025

https://ijbpas.com/pdf/2025/May/MS_IJBPAS_2025_8984.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.5.8984