Acolyte Biomedica Ltd - Articles and news items

Dave Elder, Joint Pharmaceutical Analysis Group and GSK

Foreword: ICHQ2(R1) Validation of Analytical Procedures – Challenges and Opportunities

Issue 4 2013 / 20 August 2013 / Dave Elder, Joint Pharmaceutical Analysis Group and GSK

The International Conference on Harmonisation (ICH) guideline for the Validation of Analytical Procedures (ICHQ2(R1)) currently covers validation procedures for the four most common analytical tests: identification tests, quantitative tests for impurities, limit tests for the control of impurities and quantitative tests for the active moiety(ies) in APIs (active pharmaceutical ingredients) or drug products. The key underlying concepts and strategies are equally applicable to other analytical methodologies; e.g. particle size analysis, dissolution, etc. Typical validation parameters covered in the guideline include accuracy, precision, specificity, detection limits (DL / LOD) and quantitation limits (QL / LOQ), linearity, range and robustness.

Recent development in Rapid Microbiology Methods

Issue 5 2008, Past issues / 29 September 2008 /

Microbiology is the scientific study of micro-organisms and includes many sub disciplines like bacteriology, virology, mycology, and parasitology: all characterized by the study of organisms too small to be seen by the naked eye. This defining aspect has determined the focus of microbial research over the last century: the need to selectively concentrate or amplify micro-organisms or their components to detect their presence. Earlier efforts into microbial detection involved microscopy, where light was transmitted through or reflected from the sample through lenses to magnify the view of the sample and determine the presence of micro-organisms. The limitations of light microscopy at the time prevented the study of living micro-organisms and it wasn’t until Pasteur (1822-1895) developed techniques to disprove the theory of spontaneous generation, and Robert Koch (1843-1910) developed his ‘postulates’ proving that diseases were caused by specific bacteria, was the era of microbial culture born.


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