BioPharm International - May 2021

BioPharm - Partnerships for Outsourcing - May 2021

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Page 18 of 39

18 BioPharm International eBook May 2021 Ensuring Contract Manufacturing Facilites Are Up to Speed The COVID-19 pandemic has triggered additional considerations to supplier oversight of contract manufacturing facilities. T he rapid sc a le up for ma nu fac t u r i ng of COVID-19 vaccines pressured vaccine devel- opers, 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 pro- duction 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 over- sight can complicate regulatory approval for a facility and impact the qualit y 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. NEW FACILITIES AND MANUFACTURING LINES BioPharm: How can CMOs/contract development and manufacturing organizations (CDMOs) and sponsor com- panies work together to ensure new facilities or manufac- turing lines are approved by regulators? How does this change during a pandemic? SUSAN HAIGNEY Partnerships for Outsourcing Quality/Regulations SASHKIN - STOCK.ADOBE.COM

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