Seal of quality for LANXESS subsidiary: Saltigo passes FDA audit
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.”
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Topic world Synthesis
Chemical synthesis is at the heart of modern chemistry and enables the targeted production of molecules with specific properties. By combining starting materials in defined reaction conditions, chemists can create a wide range of compounds, from simple molecules to complex active ingredients.
Topic world Synthesis
Chemical synthesis is at the heart of modern chemistry and enables the targeted production of molecules with specific properties. By combining starting materials in defined reaction conditions, chemists can create a wide range of compounds, from simple molecules to complex active ingredients.