Modules

Core Module Information
Module title: Quality Control & Pharmaceutical Analysis
SCQF level: 11:
SCQF credit value: 20.00
ECTS credit value: 10
Module code: MIC11113
Module leader: Giacomo Russo
School School of Applied Sciences
Subject area group: Life Sciences
Prerequisites

There are no pre-requisites for this module to be added
Description of module content:

You will develop an appreciation and understanding of solid dosage form manufacture carried out in industry and the quality control tests performed before a final dosage form reaches the market. You will gain knowledge of the combination of ingredients that make up pharmaceutical and nutraceutical formulations (API & Excipients) and the different types of tests, required at different stages in order to comply with the high standards required by regulatory authorities such as the FDA and MHRA. In the laboratories, you will gain hands-on analytical experience on industry-standard equipment including HPLC and UV instrumentation. You will become familiar with different types of chromatography and learn how to operate, maintain and troubleshoot these techniques. You will learn how to handle and prepare solid dosage forms for analysis by spectrophotometric and chromatographic analytical procedures and you will maintain GLP/GMP compliant lab books. You will benefit from guest lectures and workshops from industry-based professionals from CMOs (contract manufacturing organisations) and CROs (contract research organisations) which will give you the insight necessary and preparation for work in the pharmaceutical, health, medical devices and food industry. Formulated drug products (FDPs); Active Pharmaceutical Ingredients (APIs); and excipients which make up the formulation, binders, disintegrators, solubilizers, taste masking agents. How choice of excipients determines parameters such as PK (pharmacokinetics) and route of administration of the medicine. A range of batch release tests conducted by the industry defined by the appropriate Pharmacopeias; raw material testing, validation batch testing, assay of active content, degradation and stability studies, dissolution profile testing, uniformity of dosage units and physical characterisation.Instrumental analytical techniques including UV/Vis spectrophotometry, TLC, HPLC and Mass spectrometry. Theoretical and practical knowledge of different types of chromatography. Practical HPLC operation for analysis of pharmaceutical samples, maintenance and troubleshooting. Mobile phase preparation, standards and sample preparation and API extraction for analysis. Analysis and quantification of multi-component systems. Knowledge of ICH guidelines and regulatory standards (such as MHRA) and processes for originator, generic and biopharmaceutical industries.Maintenance of a GLP compliant lab book and knowledge of GMP.
Learning Outcomes for module:

Upon completion of this module you will be able to

LO1: Appraise and understand the differences between an API (Active Pharmaceutical Ingredient) and an FDP (Formulated Drug Product); and critically explore how the final dosage form is formulated.

LO2: Evaluate the fundamental science of the physicochemical properties of selected drugs in their native and formulated dosage forms.

LO3: Critically assess the elements of Quality Control (QC) and Batch release testing procedures on final dosage forms required by the respective Pharmacopeia (BP, USP, IP, JP) and the specifications that the products must meet.

LO4: Accurately assess the importance of GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) in research and manufacturing organisations; critically examine the impact of non-compliant medicines.

LO5: Evaluate the importance of, and perform sample and standard preparation in chromatographic analysis (including High Performance Liquid Chromatography).

LO6: Appraise the theory of High Performance Liquid Chromatography (HPLC) and expedite its operation, maintenance and troubleshooting.
Full Details of Teaching and Assessment
2026/7, Trimester 2, In Person, Edinburgh Napier University
VIEW FULL DETAILS
Occurrence: 001
Primary mode of delivery: In Person
Location of delivery: SIGHTHILL
Partner: Edinburgh Napier University
Member of staff responsible for delivering module: Giacomo Russo
Module Organiser:


Student Activity (Notional Equivalent Study Hours (NESH))
Mode of activityLearning & Teaching ActivityNESH (Study Hours)NESH Description
Face To Face Lecture 20 Lectures will be in person and recorded weekly on Panopto. Slides and other materials will be provided prior to the lecture to allow you to access at a time most suitable for you. The lecture recording will include subtitles/close-captioning and a transcript.
Face To Face Practical classes and workshops 20 Practical laboratory classes will allow you to apply theory introduced during the lectures/tutorials to answer an analytical question in the lab. You will work independently to build basic lab skills weekly culminating in the use of HPLC instrumentation. You will learn to keep a GLP/GMP compliant lab book and work in a simulated GLP-like environment. You must attend the lab having read the risk assessment and with calculations already prepared. You will be supported by teaching staff throughout.
Face To Face Tutorial 12 Workshop/tutorials will be offered focused on; essential lab mathematics (a primer for the lab sessions), the application and interpretation of Mass Spectra, and a revision tutorial focusing on the oral component of assessment. These tutorials are facilitated by the lecturer and peer supported. This is intended to support all students in the tutorial to learn from each other fostering an assessment for learning approach.
Online Guided independent study 145 Throughout the trimester, you are expected to structure in time to reflect upon the learning you have undertaken in your scheduled sessions and to complete your essential reading. You are encouraged to read more widely around the topics you are studying and engage in Moodle activities and resources. You will need to ensure that you have sufficient time to prepare and plan for your assessment tasks.
Online External visits 3 Industry Insights - A number of visiting lecturers will be invited annually from companies in the locality to give you an insight into the Pharmaceutical and Medical Devices industries in Scotland. Speakers from Charles River Laboratories, Almac, Roslin CT, SASA government labs, Waters are among those who have visited as part of this module in the last few years. Topics such as regulatory compliance, quality assurance, pharmacovigilance are touched upon, along with interview skills.
Total Study Hours200
Expected Total Study Hours for Module200


Assessment
Type of Assessment Weighting % LOs covered Week due Length in Hours/Words Description
Oral Assessment 50 1~2~3~4~5~6 Week 14 HOURS= 15 minutes For this assessment, you will be interviewed by at least two members of staff on material covered in this module, generally held online. The purpose of this form of assessment is to mimic a job interview in a real-life setting. Therefore, we hope you find it a useful exercise. You will be asked questions covering the module material and you will also be asked to interpret/troubleshoot a data related question (e.g. a HPLC chromatogram or Mass Spectrum). Further information can be accessed on the module Moodle page.
Practical Skills Assessment 50 1~3~5~6 Week 12 HOURS= 4 hours The first component of assessment allows you to demonstrate the skills you have learned throughout the laboratory sessions to complete a particular analysis. On the day of the practical, you will be given a brief with information on the type of analysis you are expected to perform (based on the completed practical sessions). You will be required to use the knowledge you have, and equipment/reagents available to you, to solve the analytical question posed. You must work independently, efficiently and in a GLP compliant manner to complete the practical and write up within the 4 hour window allocated to you. Marks will be allocated based on the marking criteria provided, including marks awarded for housekeeping, labelling and GLP compliance.
Component 1 subtotal: 50
Component 2 subtotal: 50
Module subtotal: 100

Indicative References and Reading List - URL:
Quality Control & Pharmaceutical Analysis
 

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