Quality Unit and HSE management

Although both were introduced from the foundation of Helsinn Chemicals SA in 1984 under the stringent Swiss Laws (Swiss Medic authorization to produce API’s and environmental laws), the current system was implemented in the middle of the 90’s with the change to a 3 level corporate quality assurance system and the first successful FDA inspection in 1996. In addition , our increased contract manufacturing activities world-wide created a regular stream of audits from our partners, each audit being and opportunity to check and improve our QA approach. One result was that the five day pre-approval inspection from the FDA of the swiss site for Palonosetron (ALOXI®) in 2003 went smoothly and without any 483. Helsinn has also believed in the concept of Safety through Quality which ensures that by working to high standards our products will be safe, our plants will be safe and our employees will safe. For HSE, Helsinn has always been concerned about introducing safe processes in the production from the beginning. A careful process risk analysis, waste control and treatment and understanding of the processes in-house is key in order to avoid any possible accident. Also a collaborative and open discussion with the local authorities has confirmed Helsinn’s commitment. The ISO 14001 and OHSAS 18001 certifications in Ireland and Switzerland where at the end simple formalities to confirm and fine tune the system in place.

environment and safety
• ISO 14001 certified in Switzerland & Ireland
• OHSAS 18001 certified in Switzterland
• full process risk analysis
• HSE (Health Safety & Environment) evaluation & management system