Our quality standards are certified
At Zach System we have advanced multi-purpose systems and a culture of quality that has seen us through us 8 years of FDA inspections without Form 483:
- The plant at Avrillé was inspected for the first time in 1984, and since 2000 it has been checked every year by various regulatory agencies. No Form 483 from 2010 to 2017, the year of the last inspection.
- All our plants conform to cGMP and are FDA-approved. Avrillé is certified UNI EN ISO 14001 (environmental management system, 2002).
- We guarantee compliance with the highest international standards – FDA (US), ANSM (France), PMDA (Japan), MFDS (Korea) – and audits by major pharmaceutical companies worldwide.