Extractables & Leachables for Injectable Formulations
Extractables and leachables can compromise the safety and efficacy of injectable formulations and are therefore subject to regulatory scrutiny. This webinar examines the studies that need to be performed for FDA submissions, an integral part of the regulatory approval process, outlining regulatory expectations in this area. Current PQRI (Product Quality Research Group) safety thresholds for injectable products are also considered. Effective extractable and leachables workflows are presented that can derisk and accelerate product development and the issue of risk assessment is discussed. Advice is given on overcoming certain common problems associated with extractable and leachables and Aptar Pharma’s expertise and services in this area are introduced.
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