Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys

Abstract

Substances that can be extracted (extractables) from the components of a medical device or a pharmaceutical product′s manufacturing, packaging, and/or delivery system(s) are characterized as part of an extractable screening study to ensure the safety of the associated therapy. While the requirements of such studies have been established on a strategic level, the tactical approaches for their execution are less controlled, and as such, have been established on a laboratory-by-laboratory basis. Based on anecdotal accounts, differences in these tactical variables have resulted in inconsistent data obtained between laboratories when all other factors are equal. To better understand this potential issue, the Lab Practices Working Group within ELSIE has conducted two surveys of the practices used by several pharmaceutical sponsors and CROs for their execution of extractable screening studies. The results obtained from these surveys uncovered a lack of alignment in some experimental variables for the execution of these studies including selection and use of surrogate standard(s), establishment of system suitability, qualification of screening methods, and use of uncertainty factors. Accordingly, it was concluded that the potential exists for at least some differences in the data obtained for extractable screening studies between laboratories due to the inconsistencies in their execution uncovered in these surveys.