Disposable plastic components of biopharmaceutical drug manufacturing systems are becoming more popular due to their cost and low contamination benefits. But the risk of using these components needs to be evaluated to determine impact to the final product. Historically each manufacturer has determined the risk by using understood risk-assessment processes, which have included established procedures, like those of BPOG (BioPhorum Operations Group), to frame a risk assessment. Currently USP has new draft sections, <665> and <1665>, that will give additional guidance regarding this risk-assessment process. The guidance will include recommendations for testing.
This webinar explores the principles behind BPOG and USP recommendations and offers insights on how to perform a single-use-component(s) risk assessment. The webinar also includes real-life examples of risk assessments and regulatory outcomes.
Learn about the presenters below.