PHRM07018 2019 Pharmaceutical Analysis

Describe the purpose of the most common analytical tests carried out in the context of pharmaceutical manufacturing and quality control.  

Relate key structural and physicochemical properties of pharmaceutical compounds to their analysis: eg appropriate analytical techniques, sample preparation and analytical conditions. 

Identify suitable sample preparation techniques for a variety of pharmaceutical samples.

Explain the chemistries of some of the phases used in instrumental chromatographic techniques.

Explain what is meant by a valid analytical method and the steps taken to ensure validity in analysis. 

Perform qualitative and quantitative laboratory analyses  on Pharmaceutical APIs and Finished Products using a selection of compendial and non-compendial methods and with due consideration of GLP/GMP

Interpret data from qualitative and quantitative chromatographic determinations in relation to a stated test hypothesis or quality specification.

This module will be taught through a variety of modes including lectures, tutorials and laboratory sessions - with individual and Team Based approaches

The aim is to blend theory and practice in gradually more applied contexts, and to allow students opportunities to self assess, explore and learn from each other within the clear framework of quality analytical methods established in compendial texts for pharmaceutical analysis and regular feedback from staff.

Beginning:  Week 1-4:Individual students work to  establish current competency levels and identify individual learning goals. Theory revises basic functional group chemistry and physicochemical properties related to a selection of  pharmaceutical compounds and laboratory activities centre around independence in basic laboratory competencies from yr 2.  Students will have the opportunity to learn from each other and peer review each others work but the focus is on individual competency. 

Middle: Week (5-10) Team focussed laboratory sessions tutorial workshops are used to allow student groups to plan, execute valid laboratory analyses using compendial and non-compendial methods and to report on results with due consideration of documentation requirements for GMP.   Lectures are provided concurrently on important fuctional aspects of the techniques used.  Students take individual responsibility for documentation, interpretation and reporting or results.

End: Demonstration of advanced techniques and Individual competencies are reviewed (Week 11-12) 

This module is 65% continuous assessment 50% practical and 15% continuous assessment theory and 35% final examination.The students must reach an assigned gate (30%) in the final examination and achieve 40% overall to pass the module

SUMMATIVE:

Practical skills, report writing and data evaluation will be assessed at regular intervals (2-3 weeks). (50%)

Theory Assignment:  Based on Application notes (15%)

Final exam (35%)

FORMATIVE:  Short questions,  MCQs  and simulated data for interpretation will be used formatively in workshops and on the moodle platform.

Repeat exam if grade in final exam is <30%

Repeat attendance may be required if attendance is less than 75% in practical sessions.

Repeat CA if all other conditions have been met and student has failed to achieve passing grade.

1. Describe the purpose of the most common analytical tests carried out in the context of pharmaceutical manufacturing and quality control.  

• Role of QC in pharmaceutical manufacturing environment
• Compendial methods: Identity, Impurities/related substances, Assay, other characteristics. 

2. Relate key structural and physicochemical properties of pharmaceutical compounds to their analysis: eg appropriate analytical techniques, sample preparation and analytical conditions. 

• Intermolecular interactions, partition coefficients, ionisation pka/buffers, sterochemistry.

3. Identify suitable sample preparation techniques for a variety of pharmaceutical samples:

• Solubility, filtration, centrifugation, solvent extraction, solid phase extraction.

4. Explain the chemistries of some of the phases used in instrumental chromatographic techniques.

• Mobile and stationary phase chemistries: HPLC/UPLC, GC, Ion Chromatography, 

5. Explain what is meant by a valid analytical method and the steps taken to ensure validity in analysis. 

• Validation requirements ICHQ2
• System suitability requirements PhEur

6. Perform qualitative and quantitative laboratory analyses  on Pharmaceutical APIs and Finished Products using a selection of compendial and non-compendial methods and with due consideration of GLP/GMP

In relation to Assays and Related Substances reviewing use of  Chemical (titration) & spectroscopic (FTIR/UV) techniques and emphasising competencies in performing chromatographic separations: HPLC (in particular), GC, Ion Chromatography. 

• Identify relevant hazzards and manage risks for safety.
• source and apply compendial method or non-compendial SOP
• Prepare samples/standards and set up instrumentation
• Record all relevant data in consideration of GLP/GMP

7. Interpret data from qualitative and quantitative chromatographic determinations in relation to a stated test hypothesis or quality specification.

• Quality specifications for pharmaceutical samples. 
• Recording and documenting 
• Processing qualitative and quantitative analytical data
• Interpretation of chromatographic data including system suitability - in relation to quality specification.