Does DSM Biomedical have cGMP certified sites?
DSM Biomedical has a forward-looking manufacturing process that is designed to help its partners successfully navigate an increasingly rigorous regulatory and quality compliance environment. Our facilities (DSM PTG) are ISO 9001:2000 and ISO 13485:2003 certified. Many elements of our quality system, from design control during the R&D stage through manufacturing release including document control, lot traceability, labeling, and product release are based on 21 CFR Part 820 guidelines and a solid QSR/ISO training program is in place for all employees. Because of our commitment to quality and to meeting our partners’ needs, our facilities are capable of performing specific manufacturing activities under cGMP principles. In addition, DSM Biomedical has created “cGMP suites” that operate under environmental and isolation controls and are outfitted with an Ultra High Purity Water System. DSM Biomedical performs many aspects of device manufacturing but we do not manufacture a Finished Device,
