Particulate contamination has been the source of multiple concerns associated with pharmaceutical safety. Between 2016 and 2019 particulates caused about 30 product recalls (approximately 10% of all recalls highlighted by the FDA) with a large proportion of these recalls associated with injectable drugs. In general, there are three major classifications of particle sources; these are inherent, intrinsic, and extrinsic and there are multiple guidelines describing test strategies to control particles (e.g. USP 787-790 and USP 1788).

During this webinar, Dr Stefan Heck, Intertek Reinach, will describe the challenges of particulate identification and the regulatory context, and with a series of case studies, he will demonstrate suitable test strategies that may be applied depending on the type and source of the observed particulate contamination.

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