THE ROLE OF EXTRACTABLE LEACHABLE TESTS WITHIN A RISK MANAGEMENT FRAMEWORK

摘要

Hazard identification and risk estimation based on toxicological properties of raw materials and intermediates is well-established as strategy for management of process-related impurities within the pharmaceutical industry. A similar approach can be applied for the selection and documentation of materials for container closure systems. This presentation outlines a strategy for risk management where analytical testing of leachables and extractables play a key role in the verification of identified hazards and estimation of the probability of critical patient exposure.