PHRM07006 2013 PHARMACEUTICAL MANUFACTURING

General Details

Full Title
PHARMACEUTICAL MANUFACTURING
Transcript Title
PHARMACEUTICAL MANUFACTURING
Code
PHRM07006
Attendance
N/A %
Subject Area
PHRM - Pharmaceutical Science
Department
LIFE - Life Sciences
Level
07 - NFQ Level 7
Credit
15 - 15 Credits
Duration
Semester
Fee
Start Term
2013 - Full Academic Year 2013-14
End Term
9999 - The End of Time
Author(s)
Geraldine Duignan, John Barrett Phd., Tom Patton, Declan Shelly
Programme Membership
SG_SPHAR_J07 201300 Bachelor of Science in Pharmaceutical Science SG_SPHAD_B07 201800 Bachelor of Science in Pharmaceutical Science SG_SPHAR_B07 201900 Bachelor of Science in Pharmaceutical Science
Description

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;

1.

Demonstrate competence in the application of a range of organic chemical synthetic techniques to the production of some common active pharmaceutical ingredients.

2.

Generate and interpret standard preformulation data on some active pharmaceutical ingredients.

3.

Propose and prepare appropriate pharmaceutical formulation based on end use and prefromulation data.

4.

Investigate the effects of processing and packaging on pharmaceutical product manufacture.

5.

Source and apply some relevant compendial tests and specifications for QC of conventional dosage forms.

6.

Perform qualitative and quantitative laboratory analyses using e.g. HPLC, GC, IC, GCMS, UV and IR

7.

Record, evaluate, interpret, and report on processing and analytical QC data at all stages with due consideration of cGMP

8.

Generate and follow Standard Operating procedures (SOP's) in the execution of key manufacturing and QC processes. 

Module Dependencies

Prerequisites
None
Co-requisites
None
Incompatibles
None

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 & Continuous Assessment
70 %
End of Semester / Year Formal Exam
30 %

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
Total Full Time Average Weekly Learner Contact Time 9.00 Hours

Module Resources

Non ISBN Literary 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.

Other Resources

None

Additional Information

None