PHRM07006 2013 PHARMACEUTICAL MANUFACTURING
This is an integrated module, which combines aspects of API synthesis, and formulation along with product processing and analysis.
Learning Outcomes
On completion of this module the learner will/should be able to;
Demonstrate competence in the application of a range of organic chemical synthetic techniques to the production of some common active pharmaceutical ingredients.
Generate and interpret standard preformulation data on some active pharmaceutical ingredients.
Propose and prepare appropriate pharmaceutical formulation based on end use and prefromulation data.
Investigate the effects of processing and packaging on pharmaceutical product manufacture.
Source and apply some relevant compendial tests and specifications for QC of conventional dosage forms.
Perform qualitative and quantitative laboratory analyses using e.g. HPLC, GC, IC, GCMS, UV and IR
Record, evaluate, interpret, and report on processing and analytical QC data at all stages with due consideration of cGMP
Generate and follow Standard Operating procedures (SOP's) in the execution of key manufacturing and QC processes.
Module Dependencies
Indicative Syllabus
This is an integrated module which combines aspects of API synthesis and formulation along with product processing and analysis.
Practical sessions will include,
Generation of Standard Operating Procedures (SOP's)
Active Pharmaceutical Ingredient (API) synthesis
QC of API's using compendial methods and microbiological techniques
Product Formulation
QC of finished product using compendial and other methods:
Emphasis on chromatographic techniques for quantitative and qualitative analysis particularly HPLC
- Practical aspects of HPLC analysis
- System suitability requirements
- Data interpretation and reporting
- Sample preparation (API vs Finished Product)
Emphasis throughout is on awareness of GMP / GLP requirements in a pharmaceutical environment.
Coursework & Assessment Breakdown
Coursework Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | Practical Evaluation Performance in laboratory sessions | Formative | UNKNOWN | - % | OnGoing | 1,2,3,4,5,6,7,8 |
2 | Group Project Maufacturing process and QC reports | Continuous Assessment | UNKNOWN | 70 % | OnGoing | 1,2,3,4,5,6,7,8 |
End of Semester / Year Assessment
Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
---|---|---|---|---|---|---|
1 | Final Exam | Final Exam | UNKNOWN | 30 % | UNKNOWN | 1,2,3,4,5,6,7 |
Full Time Mode Workload
Type | Location | Description | Hours | Frequency | Avg Workload |
---|---|---|---|---|---|
Lecture | Tiered Classroom | Lecture | 3 | Weekly | 3.00 |
Laboratory Practical | Science Laboratory | Laboratory Practical | 6 | Weekly | 6.00 |
Independent Learning | UNKNOWN | Self Study | 6 | Weekly | 6.00 |
Module Resources
Ghosh,T. and Jasti, B Theory and practice of contemporary pharmaceutics Boca Raton : CRC Press, 2005.
Gibson M; Pharmaceutical preformulation and formulation : a practical guide from candidate drug selection to commercial dosage form; Boca Raton, Fla. : Interpharm/CRC, 2004.
Pharmaceutical packaging technology. London ; New York : Taylor & Francis, 2000.
Pharmaceutical production facilities design and applications. Cole, Graham. London ; New York : Taylor & Francis, 2000.
Encyclopaedia of pharmaceutical technology second edition, 2004, J. Swarbrick.
Quantitative Chemical Analysis, Daniel C. Harris, 7th Edition, 2006.
Practical Laboratory Skills Training Guide: HPLC, E. Prichard, B Stuart, RSC, 1st Ed., 2003.
Chromatography: Concepts and Contrast, James Miller, Wiley, 2005.
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