Do you have recommendations for deciding how detailed the evaluation of extractables and leachables need to be? I know it is up to the company to decide but are there some guiding principals? Also, how is the work split between company and supplier when doing these evaluations. Is there some documentation that you will provide as part of the process?

Answer

A drug safety profile should be clinical-phase appropriate and based on patient risk. Considerations regarding extractables / leachables are an important part of the risk assessment. A number of factors need to be evaluated as part of the assessment including the interactions between process, fluid stream, and the single use assembly. The level of detail about extractables / leachables required for the assessment will depend on the users experience and historical data on the single-use systems, as well as the nature of the chemical composition of the single-use systems and the formulations that will come in contact with them. In recent years, GE Healthcare has invested in expanding our internal capabilities for characterizing the materials used in our single-use systems. We provide information about our single-use systems such as the materials of construction, biocompatibility data, as well as profiles of extractables. This type of information can be leveraged in combination with user-generated in-process leachables data as inputs into the risk assessment. More details on this topic can be found in the PDA Technical Report No. 66 Application of Single-Use Systems in Pharmaceutical Manufacturing.