Supply Assurance

Quality & Compliance

Asymchem Supply Assurance Quality & Compliance

Going Beyond What’s Required

As part of our commitment to the highest quality standards in all aspects of our operations, Asymchem has successfully implemented our Quality Policy and Management System, ensuring compliance with cGMP and ICH Q7/Q8/Q9/Q10/Q11, as well as 21CFR 211/210 guidelines. As a result we meet or exceed regulatory requirements of the USFDA, the EU, China, and other countries. In fact, we have successfully hosted more than 300 domestic and international customer audits and our production has supported launching drug products in more than 96 countries and regions.

Regulatory Compliance includes:

  • Received and passed pre-approval and GMP surveillance inspections from various regulatory agencies from around the world
  • USFDA – 13 inspections since 2011 (most recent in 2022, desktop assessment)
  • Australian TGA (2015, 2019, 2022, remote audit)
  • Korean MFDS inspection (2017)
  • China NMPA inspection (2019, 2020, 2021)
  • Live virtual audits upon request