PT - JOURNAL ARTICLE AU - Zhao, Cathy AU - Burnard, Edwin AU - Beyer, Joanne AU - Samuel, Robin AU - Budhavaram, Naresh TI - Survey Report on Complaints Related to the Interconnectivity between Vial Containers and Transfer Devices AID - 10.5731/pdajpst.2021.012643 DP - 2022 Mar 01 TA - PDA Journal of Pharmaceutical Science and Technology PG - 163--176 VI - 76 IP - 2 4099 - http://journal.pda.org/content/76/2/163.short 4100 - http://journal.pda.org/content/76/2/163.full SO - PDA J Pharm Sci Technol2022 Mar 01; 76 AB - 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 the nature of the manufacturers who received the complaints. The survey was distributed to the 16 companies participating in the working group, and 11 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 article, the analysis and outcomes of the survey will be presented, and the next steps will be discussed.