On Wednesday, March 10th 2021, WebMD posted an article with information on the newest vaccine plant the FDA are allowing to produce COVID-19 vaccines. This plant is owned by Pfizer, located in Kansas and is now booked to produce the most urgently needed drug product. Although, there is one main concern; there is a known history of mold and bacteria problems at this specific manufacturing location. This issue has been acknowledged by both, Pfizer and the FDA throughout multiple inspections, and they have yet to shut down this manufacturer. There has been many reports since Pfizer took over operations in late 2015 from the FDA that this plant has failed to control quality and contamination. The long history of mold concerns led for the FDA to do at least 4 intense inspections.
After many years knowing about the mold, during the inspections in Jan. 2020, managers at the Pfizer plant stated they decided to add “more cleaning activities in response to mold” after the 2018 inspection they had, but they still found discrepancies during that inspection in 2020. It was stated that being involved with this lab manufacturer: “We are confident in the McPherson site’s ability to manufacture high-quality COVID-19 vaccine”. There will be more eyes focused on this facility while they are creating the vaccine, to ensure quality is follows USP<790> and <1790>.
So far, there has been no issues involving or related to previous mold concerns. With InQuest Science’s Identifier Software, we can help assure and prevent quality control and contamination issues with our lifecycle management approach. This expert system is the first to fill the monitoring gap across the visual inspection, particulate and physical defect control lifecycle of sterile products and devices. The digital platform consolidates defect management and inspection qualification data meeting cGMP regulatory expectations. Process data is readily available, in real time, to authorized users, manufacturing and quality personnel across an organization. The Identifier Software also supports USP<790> and <1790> Visual Inspection Guidelines and is also 21 CRF part 11 compliant. Read the full article and learn more about Pfizer’s Vaccine plant and mold history.