module specification

MS7049 - Industrial Pharmaceutical Technology and Controls (2017/18)

Module specification Module approved to run in 2017/18, but may be subject to modification
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
152 hours Guided independent study
48 hours Scheduled learning & teaching activities
Assessment components
Type Weighting Qualifying mark Description
In-Course Test 40%   In-Class Test (1 hour)
Coursework 60%   Essay (3000 words) *FC*
Running in 2017/18
Period Campus Day Time Module Leader
Spring semester North Monday Morning

Module summary

The aim of this module is to provide the student with an in-depth understanding of manufacture of pharmaceuticals with emphasis on quality and regulatory controls.

Prior learning requirements

No pre-requisite module is required

Module aims

 To enable students to gain a comprehensive understanding of the regulatory and quality systems required for development of pharmaceuticals.
 To enable students to gain an in-depth knowledge of manufacturing processes from small scale to commercial scale.
 To illustrate and present a pharmaceuticals industry perspective of manufacturing and development of pharmaceuticals in the 21st Century


 The drug development cycle from pre-clinical to post market
 The role of Regulatory Agencies in the drug development cycle
 Quality systems and facilities
 Manufacture and scale up processes and associated controls
 Principles and implementation of Quality by Design and PAT (Process Analytical Technologies)
 The manufacture of unlicensed medications
 Counterfeit medicines
 The Patent Process
 Pharmacoeconomics
 Drug manufacture case studies

Learning and teaching

Students will be provided with the opportunity to acquire knowledge of the subject matter through lectures (22 hours), tutorials (16 hours) and workshops (10 hours). 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’ 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 successful completion of this module students will 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 in the pharmaceutical industry.
3. Define and critically appraise strategies for manufacture of pharmaceuticals.
4. Demonstrate a comprehensive understanding of emerging strategies for development and  manufacture of pharmaceuticals.

Assessment strategy

The module will be summatively assessed by means of an in-class test (40% of the overall mark) and an essay (60% of the overall mark).

To pass the module students need to achieve a minimum aggregate mark of 50%.

Component  Learning outcomes
In-class test  1, 2, 3
Essay              1, 2, 3, 4


Elliott R. and Payne K. (2004). Essentials of Economic Evaluation in Healthcare. Pharmaceutical Press.

Harman R. J. (2004). Development and Control of Medicines and Medical Devices. Pharmaceutical Press.

Medicines and Healthcare products Regulatory Agency (2007). Rules and Guidance for Pharmaceutical Manufacturers and Distributors. Pharmaceutical Press.


Review articles:
EU legislation :

Jiang W and Yu L. W (2009).  Chapter 38 - Modern Pharmaceutical Quality Regulations: Question-based. In: Developing Solid Oral Dosage Forms, Chapter 38: 885-901

ICH quality guidelines (Q1 to Q11)

Standing J.F. and Tuleu C (2005). Paediatric formulations — getting to the heart of the problem.  International Journal of Pharmaceutics, 300 (1-2): 56-66

Wertheimer A.I. and Norris J (2009). Safeguarding against substandard/counterfeit drugs: Mitigating a macroeconomic pandemic. Research in Social and Administrative Pharmacy, 5: 4–16.