Regulatory Considerations for Analytical Methods in Pharma

The pharmaceutical industry is one of the most regulated industries on the planet due to the impact that drugs can have on human health. In this webinar a brief history of the development of the regulatory agencies will be given from the very first FDA official through to the initiation of the ICH.

The growth of the regulatory bodies has been matched by scientific advances, in particular in the field of separation science where HPLC and latterly HPLC-MS improvements have substantially supported the development of new regulatory guidelines. The focus of the presentation will be on the impact of new regulations on the manufacturing and drug development process. Moreover, how chromatography has enabled scientists to better understand the drug manufacturing process and ensure that drugs are safe and efficacious. Examples will be given of how chromatography has helped in the quantification of a series of genotoxic compounds, in this case nitrosamines, present in the final formulation.

Finally, the impact of the introduction of ICH Q14 on the field of separation science and the approaches to developing a validated assay will be discussed in relation to the method development strategies when applied to small molecule analysis. ICH Q14 has substantially changed the approaches adopted by organisations with a greater focus on a more deterministic approach to method development. In turn, the manufacturer has a larger responsibility to better qualify the mode of separation that a chromatographic column is employing. The presentation will look at these modes of characterisation and relate this to ICH Q14, and the method development process.

For more information, please contact us at webinar@avantorsciences.com