Saltigo’s Managing Director Wolfgang Schmitz is delighted that the official auditors did not have any objections: “The FDA audit is an internationally accredited seal of quality and recognizes all the work we have put in. This shows not just U.S. customers but also pharmaceutical companies throughout the world that with us the production of active ingredients is in safe and reliable hands.”
The audit focused on testing production and quality assurance processes for an active ingredient that a Saltigo customer is looking to supply in the United States in the near future. It involved the auditors inspecting Saltigo’s production and quality assurance systems in Leverkusen over five days. As part of this pre-approval inspection, the FDA assesses whether a medical product can be manufactured at the company’s production facilities using technology that is recognized in the United States as state-of-the-art and in compliance with applicable CGMP rules (Current Good Manufacturing Practice).
The auditors also inspect quality assurance systems and all the facilities used, from water treatment plants and cleanrooms to filling plants and process control technology. Immediately afterwards, the FDA announces the results of its audit, ranging from “No Findings” and “Form 483” (negative findings observed) to the “Warning Letter” (critical negative findings).
“An FDA audit is a particularly tough test,” says Dr. Carsten Hesse, responsible for quality assurance in the Pharma business line at Saltigo. “This excellent “No Findings” result is a testament to our high standards. But meeting CGMP requirements with ease and flexibility and doing so in all scales of synthesis is all in a day’s work for us.”
The Saltigo service portfolio ranges from synthesis design and process development and optimization to support for registration and approval.
Saltigo GmbH is a leading supplier in the field of custom synthesis. The company of specialty chemicals group LANXESS belongs to the Advanced Intermediates segment, which achieved total sales in 2009 of EUR 1,104 million. Saltigo, headquartered in Langenfeld and with production facilities in Leverkusen and Dormagen, employs around 1,400 staff worldwide. LANXESS Corporation (lanxess.com) operates a site for Saltigo in Redmond (Washington, United States).