ELSIE's Lab Practices Working Group's Proposal for Best Practices to Improve the Consistency of Extractable Screening Data Between Laboratories

Substances that migrate (leachables) into a pharmaceutical product from the materials that comprise its manufacturing, packaging, and/or delivery system(s) have the potential to negatively impact its safety and/or quality. Mitigating the impact of this interaction typically includes the screening of substances that can be extracted (extractables) from these materials using appropriate solvents and exposure conditions. Because extractables can be predictive of product leachables, the data obtained from extractable screening studies are used to establish the safety and quality of the material(s) being assessed.

Despite the importance of extractable screening studies in assuring product quality and patient safety, it has become apparent that inconsistencies in the execution of these studies between laboratories have resulted in the potential for significant differences in the qualitative and/or quantitative aspects of the extractable profiles obtained. Given that such differences can have a significant impact on the validity of the safety assessments performed, it is critical that they be understood and eliminated.

Since this issue was discovered primarily through anecdotal accounts, the “lab practices” working group within the Extractable/Leachable Safety Information Exchange (ELSIE) conducted two industry surveys that inquired into critical aspects of extractable screening study design and execution. After completion of these surveys, it was concluded that there were numerous areas associated with the execution of extractable screening studies where labs were not well aligned that are likely having a significant impact on the data generated.

To that end, this presentation will summarize the best practice recommendations proposed by the ELSIE lab practices working group to address the discrepancies in extractable study design and ultimately produce more consistent and reliable extractable profiles between laboratories.