Meets potent compound safety certification standard
SafeBridge Consultants, based in Mountain View, California, US says Excella’s plant in Feucht, Germany meets its potent compound safety certification standard and is competent and proficient in the safe handling of potent active pharmaceutical ingredients (HPAPIs) and drug products.
The certification applies only to specific laboratory and manufacturing areas involved in the manufacture of oral solid dosage (OSD) forms at the plant. Excella is the first company worldwide to achieve SafeBridge potent compound safety certification for the manufacture of OSD forms.
SafeBridge conducted a 60-part review of health and safety programmes, procedures, containment and exposure control of OSD operations with HPAPIs at the Feucht site.
Since SafeBridge began its certification programme in 1999, 11 organisations have achieved the required standard.
Excella is part of contract manufacturing organisation Fareva Holding, headquartered in France, and offers development, clinical supply and commercial manufacturing of HPAPIs and solid dosage forms containing critical actives with low occupational exposure levels.