BioPharm International - October 2021

BioPharm-October 2021-Regulatory-Sourcebook

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10 BioPharm International eBook October 2021 Serialization and Aggregation from a Manufacturing Perspective For some manufacturers, the goal was to be fully compliant with the DSCSA, including both serialization and aggregation, from day one. E nacted by Congress on Nov. 27, 2013, the US Dr ug Supply Chain Securit y Act (DSCSA) is i ntended to bu i ld a more sec u re supply chain in the United States w ith the abilit y to identify and trace drug products and limit exposure to counterfeit, contaminated, and other w ise harmful drugs. Ever yone in the pharmaceutical supply chain has had to pivot to meet the DSCSA require- ments, including manufacturers, repackagers, wholesale distributors, dispensers, and third-part y logistics pro- v iders (trading partners). Manufact urers, specif ica l ly, have had to incorporate serialization into their manufac- turing and packaging lines and will eventually also have to incorporate aggregation as well. However, FDA won't require agg regation compl iance unti l Nov. 27, 2023, which was delayed from 2019. "At Catalent, we started planning and implementing serialization over f ive years ago," says Rebecca Mullis, Engineering Project Manager, Catalent Biologics. "But Catalent, being a contract development and manufacturing organization [CDMO], wanted to be ahead of the curve and ahead of our competitors to have serialization available for our customers. In doing so, we evaluated multiple ven- dors and evaluated different types of equipment." According to Mullis, Catalent selected vendors, pur- chased equipment, and integ rated sof t wa re and data management platforms. In the process, they moved from a manual process to a more automated one. For line- level equipment, Catalent chose to work with Mettler Toledo, which included an automated print and inspec- tion station. For a cloud provider, they chose to work with TraceLink. MEG RIVERS Regulatory Sourcebook Drug Safety KADMY - STOCK.ADOBE.COM

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