Module title: Quality Control & Pharmaceutical Analysis

SCQF level: 11:
SCQF credit value: 20.00
ECTS credit value: 10

Module code: MIC11113
Module leader: David Mincher
School School of Applied Sciences
Subject area group: Microbiology & Drug Discovery
Prerequisites

N/A

2018/9, Trimester 2, Face-to-Face,
Occurrence: 001
Primary mode of delivery: Face-to-Face
Location of delivery: SIGHTHILL
Partner:
Member of staff responsible for delivering module: David Mincher
Module Organiser:


Learning, Teaching and Assessment (LTA) Approach:
Lectures, and tutorials and will cover LOs 1-4, whilst labs and workshops will cover LOs 5-6. The students will learn about the many different components making up a solid dosage form and then gain hands on experience of some of the analysis carried out within the pharmaceutical industry. Industry standard HPLC equipment will be used as a teaching tool.
Lab sessions are designed to simulate quality control tests and analyses performed in pharmaceutical companies and contract research organisations, thereby presenting a realistic employment scenario. The analytical topics covered are in line with the skills sought by employers from the pharmaceutical, biopharmaceutical and healthcare industries. The oral examination will also assess oral presentation skills as well as verbal data communication and interpretation in a scientific meeting scenario.
The module has an industry focussed approach, given that the majority of research and development takes place within the commercial pharmaceutical and allied industries. This module will provide the necessary skills and knowledge required which students can build upon to pursue a research based carrier in the pharmaceutical, nutraceutical and biotechnological industries.
Core skills covered and acquired will be universal to all of Europe, USA and even Eastern countries including the large pharmaceutical base in India. Students will be made aware and encouraged to look at the different Pharmacopeias’ for different countries and critically review the common features as well as the differences between these guidelines. For the Quality Control components of the module, the students will be able to apply their knowledge of analysis in the Pharmaceutical industry Worldwide and appreciate the different specifications for varying markets.
The module is supported by a VLE (Moodle) which is used to provide class materials (including lectures, tutorials, workshops and laboratory classes), resources such as animations, videos, direct links to relevant web-based resources, e:submission of coursework, self-assessment tests, interactive teaching resources, and independent study materials to cover expected prior-learning. Reflecting the discipline, students use a wide range of technology to accomplish laboratory work and in silico analysis.



Formative Assessment:
Formative feedback will take place in tutorials and practical workshops which will provide hands on problem-solving exercises as well as critical examination of individual case studies presented. Formative feedback will simulate API (Active Pharmaceutical Ingredient) extraction and analysis from solid dosage forms to identify problems and then solutions with some of the methods presented. (LO3-LO5).


Summative Assessment:
Summative assessment for LOs 1-6 is provided for in a formal oral examination (theory) whilst LO5 will form the basis of a practical examination and a lab book review for GLP compliance. In the oral defence examination, the students will be presented with a scenario for troubleshooting, drawing upon knowledge gained in the Lectures / tutorials. In the lab session, a standard and sample preparation and analysis exercise is performed, reflective of the work carried out within Quality Control labs in industry.

Student Activity (Notional Equivalent Study Hours (NESH))
Mode of activityLearning & Teaching ActivityNESH (Study Hours)
Face To Face Lecture 24
Face To Face Practical classes and workshops 15
Face To Face Tutorial 15
Independent Learning Guided independent study 146
Total Study Hours200
Expected Total Study Hours for Module200


Assessment
Type of Assessment Weighting % LOs covered Week due Length in Hours/Words
Oral Assessment 50 1-6 13 HOURS= 1, WORDS= 0
Practical Skills Assessment 50 5 9 HOURS= 2, WORDS= 0
Component 1 subtotal: 100
Component 2 subtotal: 0
Module subtotal: 100

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 Pharmacopeia’s; 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’s (BP, USP, IP, JP) and the specifications that the products must meet.
LO4: Accurately assess the importance of GLP and GMP 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 HPLC).
LO6: Appraise the theory of HPLC and expedite its operation, maintenance and troubleshooting.

Indicative References and Reading List - URL:

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