Statistical Process Control

In addition to the efficacy and safety of pharmaceutical products and devices, a major goal of the manufacturing process is the uniformity of products. Hence pharmaceutical companies use statistical process controls (SPC) to contain the stability, variability, and capability of the manufacturing process. This course introduces you to the basics of calibrating processes and determining standards for evaluation of the reproducibility of the products of your manufacturing process. It includes lessons on control charts, measures of central tendencies, measures of variability, and other statistical tools.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Introduction

• What Is a Process?
• Why Is There a Need to Have a Statistical Process Control?
• Emphasis on the Need for Process Understanding and Control
• Are There Any Guidelines Available for The Statistical Process Control?
• The Goal of Statistical Process Control
• What Is a Variation?
• What Are the Sources of Variations?
• What Are Control Charts?

Lesson 1: Statistical Basis of the Control Chart

• The Mean
• The Range and Standard Deviation
• Distribution of Data
• What is the Median

Lesson 2: Control Charts

• Basic Principles
• How to Plot Control Charts
• Types of Control Charts

Lesson 3: The x-Bar Charts

• Estimating Central Tendency of the Process
• What If Some Observations Do Not Appear Within Control Limits?
• X-Bar Charts Estimating Variability of the Process

Lesson 4: The Range (R) Charts

Lesson 5: The p-Charts

Lesson 6: The c-Charts

Conclusion

Glossary

Quiz