New project-based course
teaches Science- and Risk-Based Pharmaceutical Manufacturing Validation

HOBOKEN, N.J. ― The Pharmaceutical Manufacturing and Engineering (PME) Program at Stevens Institute of Technology has initiated a new course to help educate Pharmaceutical Graduate Students in some of the new concepts in Pharmaceutical Validation.

In recent years, the Food and Drug Administration (FDA) and other regulatory agencies began pushing the pharmaceutical industry to adopt Science and Risk-based approaches to pharmaceutical manufacturing. FDA initiatives such as “cGMPs for the 21st Century” “Process Analytical Technology” and the revision to the “Guideline on General Principles of Process Validation” as well as the International Conference on Harmonization (ICH) guidelines such as Q7A, Q8 and Q9 have challenged the pharmaceutical industry to implement new approaches and thinking to Pharmaceutical Validation.

Recognizing the need for “hands-on” practical experience, the PME Program created a Project-Based Educational course to allow students to gain experience in Science and Risk-based techniques through a simulated drug development project. Using the manufacture of Chocolate Chip Cookies as a model for a Solid Dosage form, the project explores the use of statistical tools such as Design of Experiments, Gage R&R, and Regression Analysis and the use risk tools such as Ishikawa diagrams and FMEA in the development and validation of a solid dosage product. Lean Manufacturing and Six Sigma concepts are also explored. The project takes teams of students from process development through product launch.

The project teams consist of several “roles” including a Project Manager, Process Development Scientist, Project Engineer, Laboratory Supervisor, Validation Engineer and a Quality Assurance Specialist. Each “role” is given a job description, a department philosophy and a bonus system is tied to their performance on the project. During the course of the project each team creates a Validation Masterplan and performs Method Validations, Equipment Qualifications, Cleaning Validation, and Spreadsheet Validation culminating in a final 3 run Process Validation.

About Stevens Institute of Technology

Founded in 1870 and celebrating 140 Years of Innovation, Stevens Institute of Technology, The Innovation University, is one of the leading technological universities in the world dedicated to learning and research. Through its broad-based curricula, nurturing of creative inventiveness, and cross disciplinary research, the Institute is at the forefront of global challenges in engineering, science, and technology management. Partnerships and collaboration between, and among, business, industry, government and other universities contribute to the enriched environment of the Institute. A new model for technology commercialization in academe, known as Technogenesis®, involves external partners in launching business enterprises to create broad opportunities and shared value.

Stevens offers baccalaureates, master’s and doctoral degrees in engineering, science, computer science and management, in addition to a baccalaureate degree in the humanities and liberal arts, and in business and technology. The university has a total enrollment of 2,234 undergraduate and 3,700 graduate students with more than 400 faculty. Stevens’ graduate programs have attracted international participation from China, India, Southeast Asia, Europe and Latin America. Additional information may be obtained from its web page at www.stevens.edu.

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