PHA-20014 - Module Specification
School of Pharmacy and Bioengineering
Faculty of Medicine & Health Sciences

Programme/Approved Electives for 2021/22

Available as a Free Standing Elective

Co-requisites

None

Prerequisites

None

Barred Combinations

None

Description for 2021/22

This module provides an integrated and fully contextualised overview of crucial topics covering the breadth of the pharmaceutical quality assurance and analysis. The context which underpins all aspects of the module is product safety, and the emphasis of the module content will focus on how analytical methods and systems provide assurances on the safety ¿ and efficacy ¿ of medicines.
The module is underpinned by the national and international regulations that frame the manufacture, distribution and use of medicines (e.g. ICH = International Council of Harmonisation, OECD = Organisation for Economical Co-operation and Development, GMP = Good Manufacturing Practice, GLP = Good Laboratory Practice). Pharmaceutical analysis is therefore discussed both from the viewpoint of the drug development process and the on-going quality assurance of the finished drug product, moving from early non-GMP investigations to the final implementation of process analytical technology. The most commonly used analytical procedures (NMR, liquid chromatography, mass spectroscopy) are discussed in detail and supported by practical exercises that develop quantitative skills. A wide range of techniques are discussed in outline, and directed study exercises are provided so that the students gain some familiarity with development tools. Experimentation and data analysis is key to an understanding of pharmaceutical quality and an examination of the essential and appropriate techniques for the acquisition and analysis of experimental data will be provided.
This module will run across Semesters 1 and 2. It contains a ¿synoptic¿ assessment, which aims to integrate the learning of the module into a single ¿real-world¿ evaluation of product safety and efficacy.
Woven throughout the module is development of essential team-working and leadership skills: group-based tasks within the laboratory classes and practical skills workshops provide students with a forum to demonstrate their potential to work in and lead interdisciplinary teams.

The module will develop students knowledge of the application of appropriate methods of pharmaceutical analysis in the development, manufacture and use of medicines and which are central to the BSc in Pharmaceutical Science, Technology and Business programme. In doing so it will develop an underpinning knowledge of pharmaceutical dosage forms in the biopharmaceutical context of routes of administration. Chemical, physical, analytical, microbiological and biological methods will be considered.

Intended Learning Outcomes

Explain the processes involved in the quality control of all aspects of pharmaceutical drug development, formulation and the manufacturing process: 2,3
Describe in detail analytical techniques employed to assure quality and safety during the drug development process and the quality, safety and efficacy of the finished drug product: 1,2
Explain the common techniques used in the analysis of biological data to arrive at safe and appropriate drug selection for a patient: 2,3
Describe the role of pharmaceutical analysis and quality assurance methods in the context of national and international standards and regulatory processes: 1,3
Describe the processes involved in the quality assurance of all aspects of pharmaceutical drug development, formulation and the manufacturing process, and how they are applied to the development and production of medicines: 1,2,3
Explain the relationship between absorption, distribution, metabolism and elimination of drugs and their physicochemical properties and formulation: 2,3
Compare and evaluate the efficiency and safety of different routes of drug administration: 2,3
Demonstrate the relationship between the design of drug product formulation, properties of the formulation, in vitro behaviour and in vivo performance: 2,3
Demonstrate competence in pharmaceutical calculations related to pharmaceutical quality assurance and quality systems: 1,2,3
Demonstrate competence in the understanding of applications of laboratory techniques in the pharmaceutical sciences and critical analysis of data generated through a series of sessions: 1,2

Study hours

Large- and small-group teaching sessions: 50 hours
Skills-based practical work: 50 hours
Directed private study, revision and assessment: 197 hours
Synoptic exam: 1 hour
Exam: 2 hours

School Rules

None

Description of Module Assessment