Practical Report

Exam

Procedures for quality control with regard to current pharmaceutical regulations. Method validation, analytical validation criteria and monitoring of data quality and processes. Issues of sample preparation of different sample types. Application of mass spectrometry to the analysis of pharmaceutical compounds. The theory and operation of mass spectrometers will be discussed including the use of coupled techniques. This will build upon the chromatography material from previous levels. Analysis of metals in pharmaceuticals with reference to current pharmaceutical industry regulations. The module will cover the theory and application of atomic spectroscopy and mass spectrometry methods including coupled methods. The testing of biologicals relevant to pharmaceuticals, including vaccines, therapeutic immunoglobulins and monoclonal antibodies using ELISA and radio-immunoassay techniques.

Advanced Pharmaceutical Analysis - 6002PHASCI

Advanced Pharmaceutical Analysis

Discuss the principles and practice of a range of advanced analytical techniques typical of those used in the pharmaceutical industry

Propose and justify a suitable programme of testing for pharmaceuticals

Demonstrate the ability to perform analyses of pharmaceuticals and report the data

Critically evaluate the quality of analytical data and determine whether an analytical method is fit for purpose