RT Journal Article
SR Electronic
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
FD Parenteral Drug Association (PDA)
SP 163
OP 176
DO 10.5731/pdajpst.2021.012643
VO 76
IS 2
A1 Cathy Zhao
A1 Edwin Burnard
A1 Joanne Beyer
A1 Robin Samuel
A1 Naresh Budhavaram
YR 2022
UL http://journal.pda.org/content/76/2/163.abstract
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.