Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.

Current Good Manufacturing Practice compliance issues in design of pharmaceutical and biopharmaceutical facilities; issues related to process flow, material flow and people flow, and A&E mechanical, industrial, HVAC, automation, electrical, and computer; bio-safety levels; developing effective written procedures so that proper documentation can be provided, and then documenting through validation that processes with a high degree of assurance do what they are intended to do; levels I, II, and III policies; clinical phases I, II, and III, and their effect on plant design; defending products against contamination; and building quality into products.

An introduction to validation concepts in plant, process, clean-up, sterilization, filtration, analytical methods, and computer systems. Learn about Good Automated Manufacturing Practice (GAMP), IEEESQAP, and new electronic requirements, such as 21 CFR Part 11. Explore master validation plans, IQ, OQ, and PQ protocols, and their relationships to GMP. Become familiar with FDA and international (EU) regulations governing current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP).

This course provides a broad overview of topics related to the design and operations of modern biopharmaceutical facilities. It covers process, utilities, and facility design issues, and encompasses all major manufacturing areas, such as fermentation, harvest, primary and final purification, media and buffer preparation, equipment cleaning and sterilization, and critical process utilities. Unit operations include cell culture, centrifugation, conventional and tangential flow filtration, chromatography, solution preparation, and bulk filling. Application of current Good Manufacturing Practices and Bioprocessing Equipment Standards (BPE-2002) will be discussed.

The course covers oral solid dosage (OSD) manufacturing and packaging in the pharmaceutical industry. Production unit operations include blending, granulation, size reduction, drying, compressing, and coating for tablets, as well as capsule filling. Packaging aspects reviewed include requirements for primary and secondary containers and labeling, package testing. The course emphasizes design, scale-up, trouble-shooting, validation, and operation of typical OSD manufacturing and packaging facilities, including equipment, material flow, utilities, and quality assurance. Topics related to cGMP, process validation, manufacturing and packaging documentation, QA and QC in OSD manufacturing will be presented. The term project required for this course involves conceptual design of a contract manufacturing and packaging facility for OSD products, including equipment selection, development of the process flow diagrams, room layouts and other design elements, as well as preparation of Standard Operating Procedures for various unit operations.

This course will introduce students to modeling and simulation applications in pharmaceutical manufacturing. The fundamentals of discrete event simulation and the use of commercially available software to develop models of various manufacturing and service systems will be introduced. Approaches to the development of conceptual and computer models, data collection and analysis, model verification and validation, and simulation output analysis will be discussed. The modeling of chemical, biochemical and separation processes in pharmaceutical manufacturing using process simulation software will be presented. Material balances, stream reports, operations and equipment Gantt charts will be developed and process debottlenecking and cost analysis will be conducted.