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Susan Haigney is managing editor of BioPharm International, firstname.lastname@example.org.
The COVID-19 pandemic has triggered additional considerations to supplier oversight of contract manufacturing facilities.
The rapid scale up for manufacturing of COVID-19 vaccines pressured vaccine developers, contract manufacturing organizations (CMOs), and regulatory authorities to bring production lines to full operation in a short time frame, while adhering to current good manufacturing practices (CGMPs). Sometimes, however, problem arise.
For example, in April 2021, FDA cited an Emergent BioSolutions’ contract manufacturing facility for multiple violations following an inspection of the vaccine production site (1). FDA instructed Johnson & Johnson to take over operations of its COVID-19 vaccine substance, which was manufactured at the site, and ordered the halt of production of AstraZeneca’s COVID-19 vaccine also produced at the facility.
Limited access to CMO facilities for vaccine and drug developers to conduct supplier inspections and oversight can complicate regulatory approval for a facility and impact the quality of the product produced. BioPharm International asked Steven Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates (RCA), to provide insight on how COVID-19 has impacted the oversight of CMOs.
Susan Haigney is managing editor of BioPharm International.
eBook: Partnerships for Outsourcing, May 2021
When referring to this article, please cite it as S. Haigney, “Ensuring Contract Manufacturing Facilities Are Up to Speed," BioPharm International Partnerships for Outsourcing eBook (May 2021).