Quality Improvement Methodologies in Pharmaceutical Manufacturing

This article is about quality improvement and specifically about how to use quantitative tools, qualitative tools and Quality improvement methodologies. Quality as "conformance to specifications" is a position that people in the pharmaceutical manufacturing industry often promote. Improving quality involves applying appropriate methods to close the gap between current and expected levels of quality as defined by standards. Quality assurance activity uses quality improvement tools and principles to understand and address system deficiencies, enhance strengths, and improve healthcare processes. A range of quality improvement approaches exist like International Organization for Standard, Total Quality Management, Six Sigma, Lean manufacturing Failure Mode Effect Analysis, European Foundation for Quality Management (EFQM) Excellence Model, Malcolm Baldrige National Quality Award, Process and Analytical Technology, Statistical process control etc.