Quality Control Testing and Pharmaceutical Manufacturing
PMCY 4510L/6510L
2 hours. 1 hours lecture and 3 hours lab per week.
Quality Control Testing and Pharmaceutical Manufacturing
Course Description
A continuation of the Pharmaceutical Techniques and Pharmaceutical
Drug Development Lab courses. A focus on major techniques involved
in drug characterization, including preformulation, drug product
manufacturing, tableting, and USP QC testing of solid oral dosage
forms. Understanding and applying good laboratory/manufacturing
practices used in the pharmaceutical industry.
Additional Requirements for Graduate Students: Graduate students will be required to do additional experiments
in the laboratory to develop in-depth understanding and prepare a
presentation and/or report.
Athena Title
QC and Manufacturing
Undergraduate Prerequisite
PMCY 4500L/6500L or permission of department
Graduate Prerequisite
PMCY 4500L/6500L or permission of department
Semester Course Offered
Offered spring
Grading System
A - F (Traditional)
Student Learning Outcomes
Students will conduct preformulating experiments in pharmaceutical product development using SEM, and XRPD.
Students will formulate development of solid oral dosage form (tablets) using the major pharmaceutical process wet granulation, spray drying, tablet compression, and pan/fluid-bed coating.
Students will perform USP quality control release testing for tablet/capsule dosage forms, using current drug product monographs, interpretation of test procedures and chapters, and acceptance criteria.
Students will understand manufacturing and analytical testing of liposomes using TEM, DLS, and Zeta Potential.
Students will develop Acetaminophen Tablets using one of three manufacturing processes.
Students will interpret and apply good manufacturing practices used in the pharmaceutical industry.
