BIOT 110 - Pharmaceutical Product Manuf.

or Program Chair Approval.
PROGRAM: Biotechnology
CREDIT HOURS MIN: 3
LECTURE HOURS MIN: 2
LAB HOURS MIN: 2
DATE OF LAST REVISION: Fall 2022

This course introduces the most fundamental knowledge and skills required for the entry level jobs in pharmaceutical product manufacturing. It focuses on the topics related to how pharmaceutical products are formulated, filled in vials, lyophilized, labeled and packaged for distribution. Basic documentation, measurement, aseptic handling as well as the fundamentals of regulatory requirements will be discussed. With the successful completion of this course, students should be ready for entry level drug manufacturing jobs in pharmaceutical companies.

MAJOR COURSE LEARNING OBJECTIVES: Upon successful completion of this course the student will be expected to:

1. Understand the overview of the pharmaceutical manufacturing operation.
2. Comprehend the regulatory guidelines and cGMP requirements overseeing the pharmaceutical product manufacturing.
3. Understand the major scientific specifications used in the parenteral product manufacturing.
4. Identify the major container closure systems.
5. Comprehend the filtration operation and validation methods.
6. Understand the science of lyophilization as well as the pharmaceutical manufacturing of lyophilized products including; clean in place (CIP), steam in place (SIP), leak testing, qualification (IQ, OQ, PQ), process validation, system monitoring, automated processes and systems, QC release testing
7. Understand the aseptic vial filling operation and clean room designations.
8. Understand the capping and inspection processes.
9. Understand the regulatory guidelines on drug product labeling and packaging processes.

• cGMP
• CIP
• Parenteral Drug
• SIP
• FDA
• IQ
• Biomanufacturing
• OQ
• Formulation
• PQ
• Aseptic process
• Vial Filling
• Gowning
• Capping
• Clean room designation
• Inspection
• Filtration
• Labeling
• Validation
• Packaging
• RECOMMENDED TEXT: Introduction to Biomanufacturing, NBC2, ISBN9781939070012, 2nd Ed.