PHRM07015 2020 INTRODUCTION TO ADVANCED PHARMACEUTICAL SCIENCE
Full Title
INTRODUCTION TO ADVANCED PHARMACEUTICAL SCIENCE
Transcript Title
INTRODUCTION TO ADVANCED PHARM
Code
PHRM07015
Attendance
N/A %
Subject Area
PHRM - Pharmaceutical Science
Department
LIFE - Life Sciences
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2020 - Full Academic Year 2020-21
End Term
9999 - The End of Time
Author(s)
Tom Patton, Yvonne Lang, Ioannis Manolakis
Programme Membership
SG_SPHAD_B07 201900 Bachelor of Science in Pharmaceutical Science (Add-on)
SG_SAPIS_J07 202300 Bachelor of Science in Applied Industrial Science (Add-On)
Description
This module introduces students to the fundamental aspects of the pharmaceutical industry 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 quality, safety and traceability for pharmaceuticals
5.
Describe the role of regulatory authorities in the Pharmaceutical industry
6.
Discuss the drug discovery and drug development processes
Teaching and Learning Strategies
Introductory course utilising on-line lectures, presentations, peer-to-peer assessment, Q&A sessions, Internet based class/group discussions
Module Assessment Strategies
100% CA, including peer-to-peer assessment, Q&A sessions, class/group discussions
Repeat Assessments
Standard arrangements
Indicative Syllabus
Introduction to Pharmaceuticals
Terminology, general requirements of pharmaceuticals the manufacturing processes and pharmaceutical companies.
Pharmaceutical Products
Classification of pharmaceuticals, topical, oral dose, parenterals, aerosol, OTC, prescription, sustained release products, biopharmaceuticals etc.
Overview of Pharmaceutical Manufacture
The manufacturing cycle in the production of pharmaceuticals. Processes of formulating, mixing, drying, micronizing, encapsulation, tableting. Product recovery and downstream processing. Solvent recovery and waste minimization.
GMP in Pharmaceutical Manufacturing
Raw Material Control and Production Procedures: batch control and identification, processing, package and labeling. 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 quality and product safety by standardizing 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).
Drug Discovery and Development Processes
Natural and synthetic products and related discovery/development processes, new product development cycle, common active pharmaceutical ingredients and their structural features, relationships between drug structure, physical and chemical properties, mode of action and life cycle.
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
100 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Q&A sessions. Group discussions | Formative | Assessment | - % | OnGoing | 1,2,3,4,5,6 |
| 2 | Short Quizzes. Essay. Assignment Work. Written Presentations. | Coursework Assessment | Assessment | 100 % | OnGoing | 1,2,3,4,5,6 |
Online Learning Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Online Lecture | Online | Online Lecture | 2 | Weekly | 2.00 |
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours
Required & Recommended Book List
Required Reading
2011 An Introduction to Pharmaceutical Sciences Biohealthcare Publishing (Oxford) Limited
ISBN 1907568522 ISBN-13 9781907568527
2011 An Introduction to Pharmaceutical Sciences Biohealthcare Publishing (Oxford) Limited
ISBN 1907568522 ISBN-13 9781907568527
"This book explains how a particular drug was discovered and then converted from lab-scale to manufacturing scale, to the market. It explains the motivation for drug discovery, the reaction chemistry involved, experimental difficulties, various dosage forms and the reasoning behind them, mechanism of action, quality assurance and role of regulatory agencies."--Back cover.
Module Resources
Non ISBN Literary Resources
Rules and Guidance for Pharmaceutical Manufacturers and Distributors Edition: 2007.
EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines.
2011 An Introduction to Pharmaceutical Sciences Biohealthcare Publishing (Oxford) Limited
ISBN 1907568522
Journal Resources
Relevant scientific journals
URL Resources
As appropriate
Other Resources
N/A
Additional Information
N/A