ISC 278 cGMP Quality Systems

Lecture: 2 Lab: 0 Clinic: 0 Credits: 2

This course focuses on the development, implementation, and ongoing maintenance of a quality system in a cGMP environment. Topics include the cGMP standard, components of cGMP quality systems, quality function roles and training, development of documentation such as SOPs, and system review procedures. Upon completion, students should be able to identify the components of a quality system and develop a quality system manual utilizing the cGMP standard.

Course is typically offered in Spring
Student Learning Outcomes (SLOs)
Upon completion of the course, students should be able to do the following:

Explain the fundamental components of a cGMP-compliant quality system.
Describe Standard Operating Procedures (SOPs) for various processes within a cGMP quality system.
Describe the various roles within the quality function and how these roles contribute to maintaining cGMP standards in an industrial setting.
Design a comprehensive quality system manual that includes policies, procedures, and documentation requirements based on the cGMP standard.
Identify areas for improvement and corrective actions to ensure ongoing compliance and system optimization.