Standard Operating Procedures

Moravek’s Quality Assurance Department develops, implements, and periodically reviews standard operating procedures (SOPs) for all activities related to the manufacture of GMP active pharmaceutical ingredients (APIs) for use in early phase clinical trials. SOPs related to GMP API manufacturing are compliant with U.S. Food and Drug Administration guidance ICH Q7 Section 19. Our Quality Assurance Department ensures that each staff member is trained in the appropriate SOPs and provides additional training as necessary.

GMP Documentation

The quality of each GMP API manufactured by Moravek is verified by comprehensive documentation that demonstrates the product is suitable for use in a clinical trial. Moravek’s Director of Quality Assurance supervises the Quality Assurance work carried out in support of the campaign, including the generation and review of documentation such as:

  • Method transfer protocol and report
  • Master batch record
  • Executed batch record
  • Drug substance release specification
  • Certificate of Analysis
  • TSE/BSE statement
  • Certificate of Compliance

All documentation is reviewed and approved prior to releasing the GMP API for use in early phase clinical trials.