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 2022/23

None

Available as a Free Standing Elective

No

Co-requisites

None

Prerequisites

None

Barred Combinations

None

Description for 2022/23

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.
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, 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.

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: 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: 1,2,3
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: 1,2,3
1,2,3
1,2,3
Demonstrate competence in pharmaceutical calculations related to pharmaceutical quality assurance and quality systems: 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:

Study hours

Large- and small-group teaching sessions: 51 hours
Skills-based work: 52 hours
Directed private study, revision and assessment: 195 hours
Exam: 2 hours

School Rules

None

Description of Module Assessment

1: Assignment weighted 20%
Practical Assessment
The practical assessment will comprise elements from multiple sessions including analytical and microbiology assessments (2000 words in length).

2: Assignment weighted 30%
Skill Assessment
There are 2 components to the assessment. In the first section students will work in groups to collect, analyse the data and prepare a series of 2 reports (1,500 words each) focusing on 2 main areas of the pharmaceutical development process (a) chemical sciences and (b) formulation assessment sciences. For the second section, students will work in groups to collect, analyse the data and individually prepare a report (c) (1,500 words each) focusing on an analytical methodology; this section could include a laboratory and/or data analysis session.

3: Exam weighted 50%
End of module examination
End of module examination will be in-situ two hours in length. This will be supported by workshops and problem classes throughout the module. Small-stakes assessments will be introduced to this component and will comprise no more than 10% of the overall module mark.