module specification

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.

No pre-requisite module is required

 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

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.

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.

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

Books:
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 : http://ec.europa.eu/health/documents/eudralex/index_en.htm

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) http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html

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.