PHARMACEUTICAL ANALYSIS AND QA/QC - 2023/4

Module code: CHEM048

Module Overview

The purpose of this module is to give students a fundamental understanding of the conceptual frameworks underpinning pharmaceutical analysis. A wide range of analytical techniques will be presented to students which are broadly divided into those used in pharmaceutical quality control and those dedicated to drug discovery, drug design and formulation. Furthermore, a range of laboratory experiments are designed to develop Good Laboratory Practice (GLP) amongst students and expose them to a number of major analytical tools used in pharmaceutical sciences. Information obtained in this module closely relates to all other modules on the study programme and together they provide a full picture of the life of pharmaceuticals from drug discovery via drug design, and drug manufacture to drug release on the market. This module provides the necessary knowledge of analytical tools and approaches used to critically evaluate the drug development life cycle to enable the development of safe and effective medicines.

Module provider

Chemistry and Chemical Engineering

Module Leader

ANTONIJEVIC Milan (Chst Chm Eng)

Number of Credits: 30

ECTS Credits: 15

Framework: FHEQ Level 7

JACs code:

Module cap (Maximum number of students): N/A

Overall student workload

Workshop Hours: 4

Independent Learning Hours: 178

Lecture Hours: 36

Laboratory Hours: 18

Guided Learning: 24

Captured Content: 40

Module Availability

Semester 2

Prerequisites / Co-requisites

N/A

Module content

The module will cover material taken from the following subjects:

 

Pharmaceutical Analysis: an overview of typical analytical methods used in the pharmaceutical industry (such as but not limited to HPLC/GC, MS, NMR, XRD, DSC, TGA) within the context of specific pharmaceutical science or cosmetic/consumer goods problems (e.g. stability studies or polymorphism). The practical sessions will include HPLC, NMR, MS data analyses, raw material and end product analysis, physicochemical characterisation of an API, and solvate/polymorph differentiation using DSC and XRPD.

 

Analytical QA and QC principles: good laboratory practice, QA/QC documentation, ICH guidelines, statistical data analysis, analytical method validation, standard operating procedures, out-of-specification, out-of-trend data

Assessment pattern

Assessment type Unit of assessment Weighting
Practical based assessment Laboratory report 1 20
Practical based assessment Laboratory report 2 20
School-timetabled exam/test In-class test 1 (2 hours) 30
School-timetabled exam/test In-class test 2 (90 minutes) 30

Alternative Assessment

N/A

Assessment Strategy

The assessment strategy is designed to provide students with the opportunity to demonstrate that they have successfully met the learning outcomes of the module.

 

  Thus, the summative assessment for this module consists of:

 


  • Laboratory report 1 - collect, interpret, critically analyse and present the experimental data related to attended laboratory sessions, (addresses learning outcomes: 1, 2 and 3)

  • Laboratory report 2 - collect, interpret, critically analyse and present the experimental data related to attended laboratory sessions this report must be on a different technique than one used for laboratory report 1 (addresses learning outcomes: 1, 2 and 3)

  • In class-test 1 - students will complete an in-class test covering the range of material related to the Pharmaceutical Analysis discussed in lectures and tutorials.  The in-class test will be designed to test their knowledge (understanding, applications and problem-solving) of the material presented (addresses learning outcomes: 1, 3 and 4)

  • In-class test 2 - students will complete an in-class test covering the range of material related to the QA/QC Principles and Statistical Analysis discussed in lectures and tutorials. The in-class test will be designed to test their knowledge (understanding, applications and problem-solving) of the material presented (addresses learning outcomes: 1, 4 and 5)



 

Formative assessment:

Informal formative assessment is conducted throughout the module during laboratory sessions, tutorials and online where students have the opportunity to engage in a variety of activities and to receive both peer and tutor feedback, with the aim of allowing students to assess their progress week by week.

 

Feedback:

Feedback and feedforward on summative assignments will be provided via SurreyLearn. This will indicate what students did well, less well, and what they need to do to improve in the future and will relate both to issues specific to the module and to transferable skills. Formative feedback will be provided throughout the module through in-class discussions and activities, and workshops.

Module aims

  • ¿ Develop the necessary analytical practical skills appropriate to the pharmaceutical and related industries.
  • ¿ Enable students to act autonomously in planning and implementing critical analysis at a professional level.
  • ¿ Familiarise students with current analytical strategies used in pharmaceutical product development and quality control that can also be an integral part of many other industries.
  • ¿ Equip students with a systematic understanding of the principles of analysis and the important role Valid Analytical Measurement (VAM) plays in the pharmaceutical industry and a variety of other industries.

Learning outcomes

Attributes Developed
001 Understand the main analytical techniques used in product development and analytical control, their applications, advantages and limitations. KT
002 Use the range of analytical tools in the lab to assess the physicochemical properties, quality and performance of individual materials, mixtures of materials and final products. KCPT
003 Critically evaluate data obtained and suggest appropriate modifications and methods for comprehensive analysis of both routine and novel sample applications. KCP
004 Statistically evaluate, validate and appraise the integrity and quality of obtained data and the effectiveness of analytical methods. KPT
005 Comprehend the powerful role played by Quality Assurance within the pharmaceutical and consumer goods industries for documenting, archiving, collating and retrieving analytical data for Validation, Product Registration, Annual Product Review, and Change Control Management and be able to self-direct the necessary regulatory principles to all these activities. C

Attributes Developed

C - Cognitive/analytical

K - Subject knowledge

T - Transferable skills

P - Professional/Practical skills

Methods of Teaching / Learning

The learning and teaching strategy is designed to:


  • Enable students to develop knowledge, skills, and critical thinking in relation to analytical techniques, quality assurance and quality control through lectures, workshops, laboratory sessions, study examples, videos, active learning/discussion sessions, and self-study with online resources.

  • Allow students to work individually and collectively to achieve analytical outcomes that mirror those common in quality control assessment, building upon previously acquired skills.

  • To maximise learning by encouraging students to be actively engaged in critical evaluation, decision-making, negotiation, evaluation of information, and the application of theory to practice, to address challenges and solve problems faced by pharmaceutical scientists.



Students will learn the principles of pharmaceutical analysis in relation to the evaluation of a range of different samples. They will learn how pharmaceutical analysis ‘fits’ within the wider pharmaceutical sciences. Furthermore, the learning and teaching strategy is designed to develop student’s confidence and competence in working with others, digital capabilities, leadership, teamwork, communication skills, employability, and professionalism.

To achieve this, learning and teaching methods will include lectures, tutorials, laboratory sessions study examples, videos, active learning/discussion sessions, and online resources. Collectively, these methods will combine guided learning, independent learning, and self-reflection. The lectures will introduce and explain key concepts, theories, and core aspects of the practical application of the issues discussed. The laboratory sessions will provide students with the opportunity to be active participants in their learning experience by undertaking interactive exercises and group discussions, demonstrating their acquired understanding and knowledge, critical thinking, and communication skills. In order to build confidence and to engage students with diverse learning backgrounds, students will be encouraged to share their thoughts, ideas, and reflections, including those relating to their own experiences.

Indicated Lecture Hours (which may also include seminars, tutorials, workshops and other contact time) are approximate and may include in-class tests where one or more of these are an assessment on the module. In-class tests are scheduled/organised separately to taught content and will be published on to student personal timetables, where they apply to taken modules, as soon as they are finalised by central administration. This will usually be after the initial publication of the teaching timetable for the relevant semester.

Reading list

https://readinglists.surrey.ac.uk
Upon accessing the reading list, please search for the module using the module code: CHEM048

Other information

Surrey's Curriculum Framework is committed to developing graduates with strengths in Employability, Digital Capabilities, Global and Cultural Capabilities, Sustainability, and Resourcefulness and Resilience. This module is designed to allow students to develop knowledge, skills, and capabilities in the following area:

 

Employability: This module allows students to develop their understanding of the latest topics within pharmaceutical analysis, as they apply it to the assessment of drug quality and stability. Students will be exposed to the latest and best available information, a proportion of which will be delivered by external speakers, giving students direct access to professionals currently working in the field and thereby supporting their future career planning for roles in pharmaceutical sciences. This will hold clear benefits in relation to their post-graduate employability as they progress to their employment or to the year in the industry. Transferable skills will be addressed as the module allows students to further practice wider attributes that will be attractive to employers in this field. The focus of the assessment strategy will help to prepare students for the realities of the world of work because it allows them to be familiar with work ethics, time management, reporting and how different types of analytical techniques are utilised in the wider context of drug discovery, formulation development and quality control.

 

Global and Cultural: In the essence of this module is the overview of the global aspects of the pharmaceutical sciences. Students will be exposed to the important aspects of globalization and also appreciate cultural differences among the student body. Furthermore, this module exposes students to many examples from different countries related to the life, production, and distribution of pharmaceutical products as well as to manuscripts written by research groups all over the globe.  

 

Sustainability: Students will develop their appreciation, understanding and critical thinking focused on the use of green solvents, novel analytical tools that shorten the time of the analysis and energy input minimization when conducting the analytical assessment. Efforts will be made to exercise their skills when selecting analytical tools for pharmaceutical purposes.

 

Digital skills: Students will be exposed to several analytical tools including HPLC, GC, MS and NMR each of which has its own software platform. Giving students hands-on experience with these systems will help them develop digital skills with industry-standard software. In addition, wherever possible remote access will be implemented so that students will have similar access to instruments as if they are based in the industry. The laboratory report will provide the opportunity to deliver a fully formatted technical report, applying transferrable skills in digital production.

Please note that the information detailed within this record is accurate at the time of publishing and may be subject to change. This record contains information for the most up to date version of the programme / module for the 2023/4 academic year.