Thoughts on the Use of Prior Knowledge in Managing the Patient Safety Risk of Extractables and Leachables from Packaging Systems and Manufacturing Components/Systems.

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.