TY - JOUR T1 - Survey Report on Complaints Related to the Interconnectivity between Vial Containers and Transfer Devices JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol DO - 10.5731/pdajpst.2021.012643 SP - pdajpst.2021.012643 AU - Cathy Zhao AU - Edwin Burnard AU - Joanne Beyer AU - Robin Samuel AU - Naresh Budhavaram Y1 - 2021/01/01 UR - http://journal.pda.org/content/early/2021/06/15/pdajpst.2021.012643.abstract N2 - To address the challenges related to the interconnectivity between vial container closure systems and vial transfer devices, pharmaceutical, elastomer and transfer device manufacturers have formed a working group under the Product Quality Research Institute (PQRI) to establish best practices for the evaluation of the assembly of vial transfer devices and vial systems. As part of the project, the first activity was to quantify the nature and frequency of issues (complaints). To this end, the working group conducted a survey with questionnaires related to categories and numbers of complaints, regions/countries where complaints were received and nature of the manufacturers who received the complaints. The survey was distributed to the sixteen companies participating in the working group and eleven companies submitted a response. Besides quantifying and ranking the frequency of issues, the survey determined what issues are common across all companies and what issues may be product-specific or specific by manufacturer. In this report, the analysis and outcomes of the survey will be presented, and the next steps will be discussed. ER -