Good Manufacturing Practice
Course Code
FA4131
Number of Credits
3
Semester
Course Type
Study Material
| Study Material | Depth |
|---|---|
| Quality Management System in the Pharmaceutical Industry | Expert |
| Personnel qualifications | Expert |
| Building and facility design | Expert |
| Production equipment management | Expert |
| Production Process | Expert |
| Quality Control | Expert |
| Self-inspection and Handling of complaints and product recalls | Expert |
| Documentation | Expert |
| Qualification | Expert |
| GMP for traditional medicine | Expert |
| GMP for cosmetics | Expert |
Graduate Learning Outcomes (GLO) carried by the course
| CPMK Code | Course Learning Outcomes Elements (CLO) |
|---|---|
| CPMK 1 | Able to outline the necessary personnel and qualifications |
| CPMK 2 | Able to explain the design of building and its layout, as well as its qualifications |
| CPMK 3 | Able to establish equipment design and explain the series of pharmaceutical preparation production processes and their qualifications |
| CPMK 4 | Able to compile and evaluate the recording, management, and control of documents |
| CPMK 5 | Able to explain the fundamental differences of GMP for drugs, traditional medicine and cosmetics |
Learning Method
- Lecture, assignment, discussion
Learning Modality
- Visual, auditorial; synchronous and asynchronous
Assessment Methods
- Quiz, assignment, mid exam, final exam