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

For academic year: 2025/26 Last Updated: 04 December 2025

PHA-20014 - Pharmaceutical Analysis And Quality Control
Coordinator: Patricia Ragazzon Tel: +44 1782 7 34767
Lecture Time: See Timetable...
Level: Level 5
Credits: 30
Study Hours: 300
School Office:

Programme/Approved Electives for 2025/26

None

Available as a Free Standing Elective

No

Co-requisites

None

Prerequisites

None

Barred Combinations

None

Description for 2025/26

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. 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 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.
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.

Aims
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. 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.

Talis Aspire Reading List
Any reading lists will be provided by the start of the course.
http://lists.lib.keele.ac.uk/modules/pha-20014/lists

Intended Learning Outcomes

Explain the processes involved in the quality control of all aspects of pharmaceutical drug development, formulation and the manufacturing process: 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: 2
Explain the common techniques used in the analysis of analytical data to arrive at safe and appropriate drug selection for a patient: 2
Describe the role of pharmaceutical analysis and quality assurance methods in the context of national and international standards and regulatory processes: 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: 3
Demonstrate competence in pharmaceutical calculations related to pharmaceutical quality assurance and quality systems: 1
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

Study hours

Tutorials: 3 hours
Lectures: 40 hours
Interactive lectures: 30 hours
Practical sessions: 15 hours
Exam: 2 hours
210 independent study hours, students will be provided guidelines and material through KLE. These guidelines and materials will cover a range of different activities that might include reading, analysis, problem solving, self tests, information search, etc.

School Rules

None

Description of Module Assessment

1: Assignment weighted 20%
Practical Assessment
For this component you must complete a laboratory based activity; further details concerning the format of each report will be provided on the KLE. You must complete a context-based practical task in the analytical chemistry laboratory that will examine the use of an analytical methodology in the analysis of a relevant sample or product. This is a laboratory-based element that comprises an experiment undertook in the chemical laboratories, this will examine your research and preparation skills, your practical skills, and accuracy in measurement, data acquisition and data handling. In this activity you will build and analyse samples, and evaluate the content by calculation with the data obtained. You will use this data to fill out the results section of your report that you will submit individually through KLE. This session is expected to be completed in 1 (one) hour and it will be supported by one LSA. This session will be a total of 3 hours to allow any extra time and repeat of data gathering. You will be provided with further details concerning the content and format of your report during scheduled supporting sessions and via the KLE, and it will be assessed upon the criteria provided.

2: Assignment weighted 30%
Skill Assessment
You must complete one assignment, further details concerning the format will be provided on the KLE. The assignment is the complete chemical characterisation of 1 or more molecules; this is individual activity and structures, tables and diagrams should be properly presented, explained and labelled. The assignment includes analysing the data provided to propose a structure, and to present the material in a manner of document to be used following QA principles. Discussion of which analytical methodologies are to be used should be presented in the assignment. This work is individual and is expected to be 1,500 words.

3: Exam weighted 50%
End of module examination
The paper will contain questions that cover each of the module themes, the questions will be written in a style which will test your ability to identify linkages between the themes. You will be given two hours to complete the paper. This exam will be held in campus. Low Stake Assessment (LSA). Five LSAs, weighing 4% for this component have been added in this component, with total weight of 20% of this component. Each LSA will focus on key elements such as writing, calculations, analysis and interpretation.

The University undertakes a continuous review of its teaching and research provision to ensure programmes are of a high quality and changes may be made to modules where it is necessary and reasonable to do so. Please be aware that minor changes to modules, such as a change to an individual assessment, can occur up until enrolment, although we endeavour to give you as much notice as possible of any changes. Details about the circumstance in which changes are made to programmes can be found in the Student Agreement, available at: https://www.keele.ac.uk/legalgovernancecompliance/governance/actcharterstatutesordinancesandregulations/studenttermsconditions/

Last Updated: 04 December 2025