DSM Pharmaceuticals has earned the SafeBridge Potent Compound Safety Certification for the handling of potent active pharmaceutical ingredients and drug products. The certification applies to a sterile fill/finish production area within the company's Greenville, NC, facility that includes a high-containment area and associated quality control labs.
SafeBridge conducted its 60-element review of programs, procedures, containment and control of APIs at the site. Quantitative results determine that DSM qualifies for the certification.
SafeBridge in July certified SAFC, a member of the Sigma-Aldrich group, for the high-potency suite for antibody drug conjugate manufacturing and process development and associated quality-control labs at a St. Louis facility. Both SAFC and DSM hold the SafeBridge certification for high-potency areas at other facilities as well. They are joined by Lonza and Ferro-Pfanstiehl as certificate holders.
- here's the announcement