For the safe handling of potent pharmaceutical compounds at Halle and Bielefeld
SafeBridge Consultants has certified Baxter’s manufacturing facilities in Halle and Bielefeld, Germany to handle potent pharmaceutical compounds.
Baxter now claims to be the only company worldwide with facilities certified by SafeBridge to handle both parenteral drug substance synthesis and parenteral drug product manufacturing and testing.
The German facilities support Baxter's BioPharma Solutions business, a contract manufacturing organisation that collaborates with pharmaceutical companies to support their commercialisation objectives. BioPharma Solutions provides scientific expertise, sterile manufacturing solutions, parenteral delivery systems and customised support services needed for parenteral products.
‘Baxter is honoured to be recognised by SafeBridge for our safe handling of potent pharmaceutical compounds and our abilities to handle and manufacture these materials to industry standards,’ said Dr Burkhard Wichert, vice president of Manufacturing Oncology for Baxter's Halle facility.
‘We take our commitment to our pharmaceutical partners seriously and, ultimately, the patients who rely on the critical medications manufactured at our facilities in Halle and Bielefeld.’
SafeBridge Certification provides an objective and scientific assessment of a company's ability to handle safely and manufacture to industry standards potent compounds such as oncology drugs, steroid and peptide hormones, and new generations of opioids.
The certification also demonstrates that Baxter manufactures these compounds not only to US Food and Drug Administration, European and German laws, but also to international industry occupational health standards. In addition to the SafeBridge certification, the Halle facility is also OHSAS 18001 and ISO14001 certified.
During the assessment SafeBridge noted Baxter's commitment to operating safely; strong collaboration between management, supervision and employees; procedures in place to support potent compound handling operations; a strong preventative maintenance programme and effective health surveillance system.
‘Baxter Oncology has established its operations in Halle and Bielefeld with safety and occupational health as cornerstones of its business in recognition of their product mix in the hazardous drug area,’ said John Farris, president and ceo of SafeBridge Consultants.