Implementing Root Cause analysis in Pharmaceutical manufacturing

  • Maariyah Tahseen
  • Maleeha Masood
  • Trapti Saxena
  • Prasanthi Domaraju Professor


In every company failure can happen. It can have reflective impact on an organization’s attractiveness. Every organization wants to achieve success in business, so, it focuses on the way to prevent let-downs in their processes. to stop the loss, to scale back the loss, the sole way out is to investigate their cause and prevent it from reoccurrence. Root cause analysis is an efficient method to achieve this particular goal. Root cause analysis may be a technique to address a non-conformance or problem to find out the real cause of particular problem. Various root cause analysis tools are used for investigation. The main aim of root cause analysis is to discover the actual cause of an observed problem, defect, or failure so to utilize this particular information to correct it. Subsequently, the search and identification of appropriate root cause should lead to the execution of CAPA (Corrective Action and Preventive Action).

Keywords: Root cause analysis,, Steps of RCA, Benefits of RCA, Tools of root cause analysis, Ishikawa (Fishbone) Diagram.


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How to Cite
Tahseen, M., M. Masood, T. Saxena, and P. Domaraju. “Implementing Root Cause Analysis in Pharmaceutical Manufacturing”. International Journal of Drug Regulatory Affairs, Vol. 11, no. 2, June 2023, pp. 54-57, doi:10.22270/ijdra.v11i2.593.

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