module specification

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.

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

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).

Dissolution enhancing technologies
3D Printed drugs
Future of drug delivery technologies

Students will be provided with the opportunity to acquire knowledge of the subject matter through lectures, tutorials and practical laboratory 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.

There will be opportunities for reflective learning after each practical laboratory session where students will interpret the data and analyse what it means in the context of quality assurance. The students are expected to independently read the provided laboratory manual that contains background information on each practical session to set the theme and appreciate the purpose at a wider scope. In certain practical sessions, the students will need to organise and pre-plan with their group members to execute the practical in an efficient manner.

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.

The module will be summatively assessed by means of one coursework and one in-class test (50% each)
To pass the module students need to achieve a minimum aggregate mark of 50%.

Component           Learning outcomes
Coursework          3, 4 (depending on the topic assessed)
In-class test          1, 2

The coursework will provide an opportunity for the student to independently research, evaluate, and critically appraise topics such as (but not limited to) modern pharmaceutical technologies or issues relating to quality assurance. For coursework, there will be a degree of flexibility that will be based on factors such as the number of students & and staff along with the changing policies to deter the use of artificial intelligence technologies. The coursework could be one of the below:
• Written coursework such as a mini scientific review (1,000 words) on selected topics.
• Presentation on selected topic
• Podcast on selected topic
• Video recording on a selected topic
• Laboratory book/proforma-based assessment

The in-class test will have a duration of 1 hour and 30 minutes.

Students will be expected to be tested on all materials covered in lectures, tutorials and practical laboratory sessions. In-class test will cover all learning outcomes. Students will be expected to be tested on all materials covered in lectures, tutorials and practical laboratory sessions.

The coursework will be due in week 8 and the in-class test will be due in week 10.

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