At the ICH meeting in Kobe, Japan in June it was decided that the ICH guidance, 'Q2(R1): Validation of Analytical Procedures: Text and Methodology' would be revised and that an additional guidance, Q14, would be prepared on the topic of Analytical Procedure Development. Since the method validation guidance dates back to 1996, it is good news that an update is in the pipeline although it may be some time before the new version is ready. It will also be very interesting to see what the new method development guidance suggests.
Hi. My name is Oona McPolin and my company is called Mourne Training Services Ltd. I am a trainer, consultant and auditor specialising in chemical analysis of pharmaceuticals and biopharmaceuticals. This blog has now retired. You can visit the new blog on the MTS website