Author(s):
Kalyani B. Pawar, Suraj M. Patil, Tejas E. Patil, Amol R. Pawar, Pankaj S. Patil, Vikas V. Patil, Kalpesh Kumar. S. Wagh
Email(s):
amolpharma9@gmail.com
DOI:
10.52711/0974-4150.2026.00056 
Address:
Kalyani B. Pawar*, Suraj M. Patil, Tejas E. Patil, Amol R. Pawar, Pankaj S. Patil, Vikas V. Patil, Kalpesh Kumar. S. Wagh
Department of Pharmaceutical Quality Assurance, [Kisan Vidya Prasarak Sansta’S, Institute of Pharmaceutical Education Boradi, 42542], Maharastra, India.
*Corresponding Author
Published In:
Volume - 19,
Issue - 4,
Year - 2026
ABSTRACT:
Six Sigma is a structured, data-driven quality management philosophy that has progressively migrated from its origins in electronics and automotive manufacturing into the highly regulated pharmaceutical sector. Its central premise—that any repeatable process can be characterised, controlled and improved so that the rate of defective output approaches 3.4 defects per million opportunities—aligns naturally with the obligations placed on pharmaceutical manufacturers by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Council for Harmonisation (ICH). This review provides a critical overview of how Six Sigma, and its hybridised form Lean Six Sigma, is currently applied across the pharmaceutical value chain, with particular emphasis on regulatory affairs. The conceptual foundations of the method are outlined, including the statistical basis of the sigma scale, the DMAIC and DMADV problem-solving frameworks, and the core toolset of statistical process control, design of experiments, failure mode and effects analysis, root-cause analysis, value-stream mapping and process-capability indices. Their integration with established regulatory frameworks such as ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality System), and with the Quality-by-Design paradigm, is discussed. Practical applications are examined in active pharmaceutical ingredient manufacturing, formulation and packaging operations, research and development, clinical trial logistics, corrective and preventive action (CAPA) systems and post-marketing surveillance. Recurring implementation barriers, including cultural resistance, deficiencies in data infrastructure and the difficulty of sustaining gains, are critically discussed. The review concludes with a perspective on the convergence of Six Sigma with Industry 4.0 enablers such as process analytical technology, real-time release testing, machine-learning-assisted root-cause analysis and digital quality management systems, which are likely to define the next decade of pharmaceutical operational excellence.
Cite this article:
Kalyani B. Pawar, Suraj M. Patil, Tejas E. Patil, Amol R. Pawar, Pankaj S. Patil, Vikas V. Patil, Kalpesh Kumar. S. Wagh. Six Sigma in Pharmaceutical Regulatory Affairs and Manufacturing: A Comprehensive Review. Asian Journal of Research in Chemistry.2026; 19(4):370-6. doi: 10.52711/0974-4150.2026.00056
Cite(Electronic):
Kalyani B. Pawar, Suraj M. Patil, Tejas E. Patil, Amol R. Pawar, Pankaj S. Patil, Vikas V. Patil, Kalpesh Kumar. S. Wagh. Six Sigma in Pharmaceutical Regulatory Affairs and Manufacturing: A Comprehensive Review. Asian Journal of Research in Chemistry.2026; 19(4):370-6. doi: 10.52711/0974-4150.2026.00056 Available on: https://ajrconline.org/AbstractView.aspx?PID=2026-19-4-13
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