BioPharm International - October 2021

BioPharm-October 2021-Regulatory-Sourcebook

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12 BioPharm International eBook October 2021 SETTING UP SERIALIZATION AND AGGREGATION FROM DAY ONE For some manufacturers, from day one, the goal was to be fully compliant with the DSCSA, including both serial- ization and aggregation. Catalent, for example, didn't wait for the 2023 aggre- gation deadline. Instead, the company worked toward full compliance from the beginning, integrating both serialization and aggregation into their manufactur- ing process immediately. "When the operators go to pack the cases, there's another piece of equip- ment with the overhead camera, and it takes a snapshot of every layer in the case and captures every serial number of every carton. Once that's done, it goes to the database and prints a label. We manually apply the label to the case, put the case on the pallet," says Mullis. "At this point, the operator will take a hand scanner and scan the serial number of every case going onto that pallet. Once the pallet is full, we'll print a separate label. That label is applied to the pallet, and it's all tied to the batch … Again, all the serial numbers are going into this database that resides on the server side. When we go to ship the product, we already have the process. This is from day one that we implemented this." After this, the product is shipped and all serialized data are stored in cloud- based storage, which is provided by TraceLink. It's also how Catalent sends the data back to the client. Li ke Cata lent, T her mo F isher Scientific also included aggregation in their initial serialization design even though it wasn't required in the ini- tial phase of serialization. For Thermo Fisher, once they selected their equip- ment a nd sof t wa re vendors, t hey moved straight to validation. "Learning the systems now and the processes and how they all tie together, that was key to developing the qualifi- cation protocols, SOPs [standard operat- ing procedures], and then training of all those individuals from packaging to IT and QA [quality assurance] as well," says David Bond, senior manager and seri- alization program lead, Thermo Fisher. "Overall, coaching of employees from all levels in the organization on a new process just so everyone was aware of what was going on and what needed to be done for serialization." S i nc e T he r mo F i s he r 's i n it i a l implementation, Bond states there have been ongoing process improve- ments to keep up with the evolving landscape for serialization. From a training perspective, specifically, there was much to learn and standardize. Bond recalls how the company devel- oped training plans for different levels and different users of the serialization system—from QA to operations. "On the operations f loor, tak ing samples became a different process for them, managing the serial num- bers, managing the overall process for serialization. It was something new initially," says Bond. "To be honest with you, a lot of packaging operators were really afraid of serialization. Just working with them and giving them that comfort level. Before you know, they were making suggestions." SERIALIZATION ON A GLOBAL SCALE Meanwhile, for manufacturers with a global footprint, such as Recipharm, serialization and aggregation involved creating a global program. Across 15 sites, Recipharm acquired equipment, hardware, and software and established a global program that took approximately three years to implement at all the sites, according to Staffan Widengren, Director Corporate Projects, Recipharm. Similar to Catalent and Thermo Fisher, Recipharm selected vendors for serialization. For equipment, the company chose Marchesini; for soft- ware and hardware, they chose SEA Vision; and for data reporting, they chose TraceLink. Widengren esti- mates the process of ordering the equipment to having the equipment installed and qualified on the site took around 10 months from when it was started to when everything was con- nected. However, it's important to note that aggregation is not a requirement in Europe as it will be in the US as of 2023. "First, it was the machine, which we took from Marchesini, and then we prepared all the documents required for that. Then we ordered the machine together with the software. The soft- ware came from SEA Vision, and it was the responsibility of Marchesini to see that the machine and the software were integrated," says Widengren. "The next step after the order—it took around six months from when the order was placed and when the machine was ready for Regulatory Sourcebook Drug Safety At Thermo Fisher, learning how the systems and processes tie together led to the development of qualification protocols, SOPs, and training. Recipharm acquired equipment, hardware, and software and established a program that took three years to implement across all global sites.

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