Excella GmbH in Feucht, Germany has met the criteria established under the SafeBridge® program for "Potent Compound Safety Certification" and has been deemed competent and proficient in the safe handling of potent active pharmaceutical ingredients ("APls") and potent drug products.
Excella becomes the first company worldwide to achieve SafeBridge Potent Compound Safety Certification for the manufacture of oral solid dosage forms ("OSO").
Excella GmbH is part of FAREVA, one of the top 10 contract manufacturing organizations in the world.
Excella GmbH provides Contract Manufacturing Services, especially for the development, clinical supply and commercial manufacturing of highly potent APls and solid dosage forms containing critical actives with low occupational exposure levels.
The company offers a cGMP compliant and FOA I EMEA I Anvisa certified environment and is serving more than 80 markets around the world including the US, EU and Japan.
The SafeBridge Potent Compound Safety Certification of Excella applies to specific laboratory and manufacturing areas involved in the manufacture of highly potent OSO.
SafeBridge conducted a 60-element review of health and safety programs, procedures, containment and exposure control of OSO operations with occupationally potent active pharmaceutical ingredients at the company's site.
Based on the quantitative results of the Potent Compound Safety Certification program, Safe Bridge certifies that Excella meets current industry standards for the safe handling of potent APls in the identified areas.
The SafeBridge® Potent Compound Safety Certification program evaluates performance with established criteria in management, compound evaluation, exposure control and communication elements of potent compound production operations.
Elements of the program include on-site assessment of the potent compound manufacturing and laboratory areas and equipment, training, toxicology and industrial hygiene.
Since program inception in 1999 eleven organizations have achieved "Potent Compound Safety Certification".
The Excella OSO facility joins eight other facilities actively involved in the SafeBridge® Certification program.