Integrated DNA Technologies (IDT), the world leader in oligonucleotide synthesis, announced that the production processes for synthetic oligonucleotides at its European headquarters in Leuven, Belgium have achieved ISO 9001:2008 certification. All three IDT oligonucleotide facilities (Coralville, Iowa, San Diego, California, and Leuven, Belgium) now offer ISO 9001:2008 certification, with the Coralville, Iowa manufacturing headquarters also providing ISO 13485:2003 certification for the manufacture of diagnostic oligonucleotides. In addition, IDT’s Leuven facility will begin offering quality control and batch record services that are consistent with Good Manufacturing Practice (GMP) requirements associated with drug development activities.
Certification followed an audit by BSI Management Systems, a prominent quality management systems registrar – requiring on-site assessments, examinations of IDT’s documented procedures, and an audit of overall operations. System quality and standards will subsequently be monitored through periodic surveillance audits of IDT’s processes, by BSI Management Systems.
The certification also marks IDT’s formal launch of a GMP analytical service for its oligo customers, who require GMP quality control and batch record services for their drug development activities. IDT has enhanced its analytical, batch recording and endotoxin testing capabilities, integrating these into the appropriate quality system infrastructure to deliver GMP solutions to its drug development customers. With this additional service, IDT now offers oligonucleotides for all applications (research, diagnostic, and therapeutic), at scales ranging from 25 nanomoles to 10 grams.