Thoughts on the Use of Prior Knowledge in Managing the Patient Safety Risk of Extractables and Leachables from...

According to the current Stage 2b version of ICH Q3E, "the quality risk management process for E&L warrants a holistic strategy, leveraging prior knowledge â¦" where prior knowledge is that knowledge (or information) which is available to support the quality risk management of E&L prior to the initiation of the risk management process. As envisioned in Q3E, prior knowledge is a powerful resource.In this Correspondence I consider the use of prior knowledge in extractables and leachables (E&L) safety risk management and suggest how prior knowledge can be used in effective and efficient safety risk assessment.