Issue link: https://www.e-digitaleditions.com/i/1420307
www.biopharminternational.com October 2021 eBook BioPharm International 13 what we call the factor acceptance test (FAT). So, we went down to the supplier for the FAT and when that was success- ful, we got approved to ship the machine to the site. And that was another two to three months, depending on when the site needed or could install it. Then we do what we call the 'site acceptance test.' Then the machine was ready for you to use for serialization packs. The last thing was to connect it with TraceLink and the customers in TraceLink." Widengren adds that, as a CDMO, Recipharm isn't allowed to connect to the European Hub. Only the mar- ket authorization holder can do that. Therefore, Recipharm reports the serial- ization data to their customers, and then their customers report it to the EU-hub. SERIALIZATION CHALLENGES For Cata lent, Thermo Fisher, and Recipharm, it seems that serializa- tion—and aggregation—efforts are well underway. But that doesn't mean there haven't been a few unexpected hiccups along the way. The biggest cha l lenge Cata lent, specif ically, has had relates to data storage. According to Mullis, because the company has been expanding, the database that houses serialized data is filling up more quickly than expected. Therefore, their current cha l lenge is f inding a way to archive the data while still maintaining data integrity and meeting requirements. " Wit h d at a m a n a g eme nt , t h i s became a big target for our data integ- rity team," says Bond. "There was an enormous volume of new data that had to be retained for specif ic regu- lations—storage backup, security all had to be considered. And of course, keeping Part 11 [21 Code of Federal Regulations Part 11] compliance in mind along with the data. Reviewing audit trails as a part of that. Data review became a key factor in manag- ing overall data for serialization." Manufacturers are the first step in the serialization process. As such, they must be the first ones to have serializa- tion—and aggregation—in place for the essential data to be accessed by down- stream partners. Hopefully, there will be no further delays due to the COVID- 19 pandemic and smooth sailing ahead for global serialization efforts. BP Regulatory Sourcebook Drug Safety SUBSCRIBE AT BIOPHARMINTERNATIONAL.COM Science & Business eBulletin News and insights about technology and regulatory issues, company changes, company updates, and conference coverage. First Look Previews the latest issue of BioPharm International ® with links to online content and the digital edition of the magazine. BioPharma Knowledge Resource Build your biopharma development and manufacturing knowledge base with the latest whitepapers, application notes, posters, and other educational resources from biopharma industry suppliers. in the biopharmaceutical industry delivered straight to your inbox by signing up. Get the latest news, research, and trends The biggest challenge for Catalent has been data storage, as the database housing serialized data fills up quickly.