Optimization of a Pharmaceutical Filling Process to Comply with Federal Regulations and Minimize Process Variability

Abstract

This article analyzes the scientific methodology that was followed to solve a problem that arose in a pharmaceutical installation after a federal regulatory inspection. The route for a robust solution was framed by a Six Sigma approach and a DMAIC methodology, among other mechanisms. Staff with different backgrounds joined as a team to contribute their knowledge and experience using statistical tools, engineering methods and scientific fundamentals to the solution process. The realization of this project will allow the pharmaceutical facility to optimize, regulate and control its filling process for the welfare of its customers and compliance with federal regulations. Key Terms ⎯ Code of Federal Regulations (CFR), Critical to Quality (CQT), DMAIC, Food and Drug Administration (FDA), Lean Manufacturing, Process Characterization, Six Sigma, Test Method Validation, Theory of Constrains.