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MODULE DESCRIPTOR
Module Title
Advanced Pharmaceutical Analysis and Quality Control
Reference PLM340 Version 1
Created June 2023 SCQF Level SCQF 11
Approved July 2023 SCQF Points 15
Amended June 2022 ECTS Points 7.5

Aims of Module
To enable students to evaluate, problem solve and develop skills in a range of advanced analytical techniques for the analysis of drugs and medicines. To enable students to understand and evaluate quality assurance and control systems for medicine manufacture.

Learning Outcomes for Module
On completion of this module, students are expected to be able to:
1 Critically understand the principles and applications of advanced analytical techniques for the determination of a drug or medicine.
2 Make informed decisions on a range of practical problems concerning analytical sample preparation.
3 Evaluate an appropriate quality assurance and control system for medicine manufacture.

Indicative Module Content
Pharmaceutical drug/medicine analysis, use of pharmaceutical monographs for the analysis of formulated preparations, extraction methods. Advanced analytical techniques include: liquid chromatography, gas chromatography, mass spectrometry, fluorescence spectroscopy, (derivative) ultra-violet spectroscopy, infrared spectroscopy. Quality assurance: Principles, procedures, test methods, records, reporting, data management, auditing and sampling; laboratory accreditation and accreditation regimes; standards GLP and GMP.

Module Delivery
The module will be delivered by lectures, tutorials and laboratory workshops.

Indicative Student Workload Full Time Part Time
Contact Hours 30 N/A
Non-Contact Hours 120 N/A
Placement/Work-Based Learning Experience [Notional] Hours N/A N/A
TOTAL 150 N/A
Actual Placement hours for professional, statutory or regulatory body    

ASSESSMENT PLAN
If a major/minor model is used and box is ticked, % weightings below are indicative only.
Component 1
Type: Coursework Weighting: 60% Outcomes Assessed: 1, 3
Description: Written report critically evaluating quality control standards for a given medicine.
Component 2
Type: Practical Exam Weighting: 40% Outcomes Assessed: 2
Description: Practical assessment of laboratory based skills

MODULE PERFORMANCE DESCRIPTOR
Explanatory Text
Component 1 (CW1) is weighted as 60% and Component 2 (PE1)as 40%. A minimum module grade of D is required to pass the module. Non-submission of either component will result in an NS grade.
Practical Exam:
Coursework: A B C D E F NS
A A A B B B E
B B B B C C E
C B C C C D E
D C C D D D E
E D D D E E E
F E E E E F F
NS Non-submission of work by published deadline or non-attendance for examination

Module Requirements
Prerequisites for Module None, in addition to course entry requirements.
Corequisites for module None.
Precluded Modules None.

INDICATIVE BIBLIOGRAPHY
1 Aulton, M.E. (2017). 'Pharmaceutics - the design and manufacture of medicines', 5th edition, Churchill Livingstone, Elsevier.
2 Khar, R.K. (2017). 'Lachman's/Lieberman's: the theory and practice of industrial pharmacy', 4th edition, CBS Publishers.
3 Prichard, E. (2007). 'Quality assurance in analytical chemistry', Wiley.
4 Skoog, D.A., Holler, F.J., Crouch, S.R. (2018). 'Principles of instrumental analysis', 7th edition, Brookes Cole.
5 Watson, D.G. (2016) 'Pharmaceutical analysis - a textbook for pharmacy students and pharmaceutical chemists', 4th edition, Churchill Livingstone, Elsevier.
6 Medicine and Health products Regulatory Agency (MHRA) (2022). ‘Rules and Guidance for Pharmaceutical Manufacturers and Distributors’, GB MHRA.

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