module specification

MS7049 - Industrial Pharmaceutical Technology and Controls (2022/23)

Module specification Module approved to run in 2022/23
Module title Industrial Pharmaceutical Technology and Controls
Module level Masters (07)
Credit rating for module 20
School School of Human Sciences
Total study hours 200
 
166 hours Guided independent study
34 hours Scheduled learning & teaching activities
Assessment components
Type Weighting Qualifying mark Description
In-Course Test 50%   In Class Test
In-Course Test 50%   In Class Test
Running in 2022/23

(Please note that module timeslots are subject to change)
Period Campus Day Time Module Leader
Spring semester North Monday Morning

Module summary

This module is designed to provide you with an in-depth understanding of the manufacture of contemporary pharmaceuticals with a particular emphasis on quality and regulatory controls. By undertaking this module you will:

  1. gain a comprehensive understanding of the regulatory and quality systems required for the development of pharmaceuticals.
  2. gain an in-depth knowledge of manufacturing processes from small scale to commercial scale.
  3. be able to illustrate and present a pharmaceutical industry perspective of manufacturing and development of pharmaceuticals in the 21st century.

Prior learning requirements

No pre-requisite module is required
Available for Study Abroad? NO

Syllabus

The drug development cycle from pre-clinical to post-market (LO 1, 4).
The role of Regulatory Agencies in the drug development cycle (LO 1, 4).
Quality systems and facilities within the pharmaceutical industry (LO 2, 3).
Manufacture and scale up processes and associated controls within the pharmaceutical industry (LO 3, 4).
Principles and implementation of Quality by Design and PAT (Process Analytical Technologies (LO 2, 3).
The manufacture of unlicensed medications and their impact on commercially licensed products (LO 1, 2, 3).
Counterfeit medicines (LO 2, 3).
The Patent Process (LO 1, 2).
A detailed analysis of the impact of Pharmacoeconomics (LO 1, 2, 3, 4).
Drug manufacture case studies (LO, 1, 2, 3, 4).

Balance of independent study and scheduled teaching activity

Students will be provided with the opportunity to acquire knowledge of the subject matter through lectures, tutorials, workshops and practical sessions. The ability to undertake scientific and critical appraisal of data will be encouraged through directed reading and tutorial/workshop discussions. Students will be expected to reflect upon taught material in order to demonstrate their understanding of the aspects of pharmaceutical manufacture and associated controls covered in this module. PDP: On completion of this module students’ will provide an evaluation of how the module allowed them to develop skills such as information technology, organisational skills, team building, communication. time management, and working under pressure.

Learning outcomes

On completion of the module, students should be able to:

  1. Understand and critically evaluate the regulatory requirements to achieve clinical trial and marketing approval in Europe and USA.
  2. Explain and evaluate in-depth the quality systems requirements within the pharmaceutical industry.
  3. Define and critically appraise strategies for the manufacture of pharmaceuticals.
  4. Demonstrate a comprehensive understanding of emerging strategies for development and manufacture of pharmaceuticals.

Assessment strategy

Students will be summatively assessed by means of two in-class tests (50% each). To pass the module students need to achieve an overall minimum aggregate mark of 50%.

Students will receive oral formative feedback during and following participation in tutorials, workshops and practical sessions, and will also be given the opportunity to receive critiques of drafts of the essay component of the module. Written summative feedback is provided on both assessment items of the module.

Bibliography