Samsung BioLogics announced on October 1st, 2018 that its Plant 3 has become cGMP ready and started production (OOF, out of freezing) after its successful validation. The company finished validation in just 10 months, 2 months faster than Plant 2 validation.
Samsung BioLogics obtained about 4,500 verification records during the self-validation. Validation is the first step for manufacturing approvals and productions as the records filed during this stage are essential to receive global approvals in the future.
Samsung BioLogics optimized and eliminated errors by applying accumulated construction and validation data and experiences from plant 1 and 2. As a result, the company was able to minimize the validation period significantly.
In particular, about 1,200 samples are gathered daily during the validation stage. If one error occurs, more than a week required for rework and verification.
To minimize such errors, Samsung BioLogics has continuously conducted previous best-practice education, standardization of sampling, and deployed experienced employees in the site where error occurs frequently. Because of these efforts, the company has reduced the error rate to as low as 0.02%.
In addition, Samsung BioLogics standardized validation documents which enables greatly shortened the time required to create and review documents. Also it took a new approach that verify one device as a representative of many that have the same mechanism. Consequently it decreased by more than 17% from 8 to 6.6 verification documents per device.
“Plant 3 cGMP ready means that Samsung BioLogics has become the largest bio manufacturing CMO in the world” but “we will continue to go forth to change the paradigm of biopharmaceutical industry with its manufacturing competitiveness,” Dr. T.H Kim, the president and CEO of Samsung BioLogics, said.