PHRM06001 2019 INTRODUCTION TO PHARMACEUTICAL SCIENCE
Full Title
INTRODUCTION TO PHARMACEUTICAL SCIENCE
Transcript Title
INTRODUCTION TO PHARMACEUTICAL
Code
PHRM06001
Attendance
N/A %
Subject Area
PHRM - Pharmaceutical Science
Department
LIFE - Life Sciences
Level
06 - NFQ Level 6
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Declan Shelly, Aodhmar Cadogan
Programme Membership
SG_SGOOD_C06 201900 Higher Certificate in Science in Good Manufacturing Practice & Technology
Description
This module introduces students to some fundamental aspects of the Pharmaceutical -Chemical sector, both nationally and internationally.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Recognise the general requirements of pharmaceutical manufacturing.
2.
Identify the main classifications of pharmaceutical products.
3.
Explain the manufacturing cycle in the production of pharmaceuticals.
4.
Discuss the importance of traceability in a GMP environment.
5.
Describe the role of regulatory authorities in the Pharmaceutical industry.
Teaching and Learning Strategies
This module will be delivered part time. It will include lectures augmented by independent learning and directed learning. Moodle will be used as a repository of educational resources.
Module Assessment Strategies
The module is 100% continuous assessment.
Repeat Assessments
Repeat assessments.
Module Dependencies
Prerequisites
None
Co-requisites
None
Incompatibles
None
Indicative Syllabus
Introduction to Pharmaceuticals
Terminology, general requirements of pharmaceuticals and pharmaceutical manufacturing processes.
Pharmaceutical Products
Classification of pharmaceuticals, topical, oral dose, parenterals, aerosol, over the counter(OTC), prescription, sustained release products, biopharmaceuticals etc.
Overview of Pharmaceutical Manufacture
The manufacturing cycle in the production of pharmaceuticals. Processes of formulating, mixing, drying, micronising, encapsulation, tableting. Product recovery and downstream processing. Solvent recovery and waste minimisation.
GMP in Pharmaceutical Manufacturing
Raw Material Control and Production Procedures: batch control and identification, processing, package and labelling. Requirements for the validation of processes and equipment and the adoption of processes controls. Safety issues in pharmaceutical manufacturing.
The Standard Operating Procedure
The importance of standardising work practices and controlling procedures in GMP environment.
Quality in Pharmaceutical Manufacturing
Role of regulatory authorities , Irish Medicines Board (IMB), European Medicines Agency(EMEA), Food and Drug Administration(FDA). International Conference on Harmonisation (ICH).
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
100 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Question and Answer sessions.Class / Group Discussions. | Formative | Assessment | - % | OnGoing | 1,2,3,4,5 |
| 2 | Assignment Work. Written Presentations. Oral Presentations. |
Coursework Assessment | Assessment | 100 % | OnGoing | 1,2,3,4,5 |
Full Time Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Group Learning | Flat Classroom | Group Learning | 2 | Weekly | 2.00 |
| Independent Learning | UNKNOWN | Self Study | 5 | Weekly | 5.00 |
Total Full Time Average Weekly Learner Contact Time 2.00 Hours
Part Time Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Not Specified | Lecture | 2 | Weekly | 2.00 |
Total Part Time Average Weekly Learner Contact Time 2.00 Hours
Module Resources
Non ISBN Literary Resources
Rules and Guidance for Pharmaceutical Manufacturers and Distributors Edition: 2007.
Journal Resources
None
URL Resources
None
Other Resources
None
Additional Information
None