Moravek’s Quality System
Moravek’s Quality System is compliant with ICH Q7 Section 19, which has been adopted by regulatory agencies including the U.S. Food and Drug Administration and provides guidance regarding good manufacturing practices for the production of active pharmaceutical ingredients (APIs) for use in early phase clinical trials.
Our Quality System involves Equipment & Facilities and Practices & Procedures
Experience
Moravek’s Quality System has successfully supported the production of over one hundred GMP APIs for use in clinical trials, all of which have met all client and regulatory body acceptance criteria. We routinely work closely with our clients’ Quality Assurance departments, resulting in a continually updated and comprehensive Quality System that consistently meets all essential compliance requirements.
Read more about GMP API manufacturingAudits
Moravek’s Quality System is continuously improving based on feedback we receive from audits by our valued clients, including some of the world’s leading pharmaceutical companies, and the California Department of Public Health – Food and Drug Branch.
We welcome audits of our facilities.