Good CAPA Practice- A Six Sigma Approach to Reduce the Coast of Non-compliance

Reham Osama Nour, Purdue University

Abstract

Within pharmaceutical and medical devices-based industries, there are no generalized or standardized procedures for design, implement, and control a compliance CAPA structure. Simultaneously, FDA observation reports and warning letters revealed that CAPA is still not fully understood by many of pharmaceutical/medical devices manufacturing community members. This study expands knowledge in the field of quality system regulation by offering methods and tools that work efficiently within the CAPA structure. while, at the same time, sustaining productivity through critical evaluation of FDA warning letters which considered a great tool for professionals and researchers. This provide a great insight on how to build in and implement the FDA regulations and requirements into companies' quality system. On the other hand, using Six Sigma DMAIC principle in improving CAPA system compliance performance helps define the bottlenecks and sources of variations within the CAPA process. Two main focus for this research, first to identify the criteria for Good CAPA Practice and second to use Six Sigma DMAIC (define, measure, analyze, improve, control) approach to enhance CAPA compliance performance and therefore decrease the cost of non-compliance. As such, Six Sigma DMAIC principle implemented to improve the CAPA system for a medical device company as a case study. Finally, a stepwise-based model was developed to ensure best compliance with FDA requirements and regulations within the whole course of CAPA system at all quality and business levels. This CAPA model significantly helps companies in their continuous improvement journey to reach out their ultimate goals at all business aspects.

Degree

M.S.

Advisors

Umberger, Purdue University.

Subject Area

Pharmaceutical sciences

COinS