BPOG MODEL SOLVENT COMPARISON FOR EXTRACTABLES TESTING FOR SINGLE USE SYSTEMS

摘要

Regulatory guidance requires an extractables based evaluation for drug manufacturing processes. Concerns about the increasing use of hyrbrid and fully single use systems in manufacturing processes and what they may contribute the bulk drug substance and final drug product has highlighted the need for thorough risk assessments and safety evaluations. Awareness of the risk each unit operation represents a strategy to deal with the risk is crucial.