A case study: application of statistical process control tool for determining process capability and sigma level.

Area of Science:

• Pharmaceutical Manufacturing
• Quality Control
• Statistical Analysis

Background:

• Statistical Process Control (SPC) is crucial for process measurement and variation analysis.
• Regulatory bodies worldwide support SPC for enhanced process control and understanding.
• SPC is a novel yet advantageous tool for pharmaceutical tablet production quality assessment.

Purpose of the Study:

• To determine the sigma process capability of tablet production processes.
• To assess process quality using statistical methods and identify areas for improvement.
• To evaluate the application of quality improvement and risk assessment for achieving six sigma-capable processes.

Main Methods:

• Risk assessments were employed for selecting critical quality attributes.
• Normal probability distributions, control charts, and capability charts were utilized for process analysis.
• Data interpretation and graph trends were used to study process stability and critical quality attributes.

Main Results:

• The study assessed production processes at the sigma level, identifying out-of-specification attributes.
• Interpreted data provided insights into process stability, variability, and trends.
• Pareto charts identified the most variable and least capable processes for targeted improvement.

Conclusions:

• Statistical Process Control is vital for pharmaceutical tablet production quality.
• The study demonstrates the effectiveness of SPC in assessing and improving process capability.
• Application of SPC principles facilitates continuous quality improvement and the development of six sigma-capable processes.