Demonstrates that API production is in safe and reliable hands
Saltigo of Germany, the custom synthesis division of Lanxess, has passed an audit by the US Food and Drug Administration (FDA).
The audit focused on testing production and quality assurance processes for an active ingredient that a Saltigo customer is looking to supply in the US 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 recognised in the US as state-of-the-art and in compliance with applicable CGMP rules (Current Good Manufacturing Practice).
Managing director Wolfgang Schmitz said the official auditors did not have any objections and issued the firm with a ‘No Findings’ rating.
‘This shows not just US customers but also pharmaceutical companies throughout the world that with us the production of active ingredients is in safe and reliable hands,’ he said.
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.
‘An FDA audit is a particularly tough test,’ said Carsten Hesse, who is responsible for quality assurance in the Pharma business line at Saltigo. ‘This ‘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 optimisation to support for registration and approval.