Course: The Validation of Analytical Methods for Pharmaceutical Analysis

The pharmaceutical industry is very heavily regulated due to the nature of its products. This course provides a thorough treatment of analytical method validation following current regulatory guidelines. The validation process of planning a study, executing the study, and interpretation and reporting of the results is described fully. The theory regarding the purpose of validation and the practical aspect of performing a study are combined in this course. The definitive reference for this topic is the guideline produced by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Q2(R1) ‘Validation of Analytical Procedures: Text and Methodology’. Sections of the guideline have been reproduced in the training materials associated with this course with the kind permission of the ICH secretariat. All ICH guidelines are available via the website, www.ich.org.