Moravek’s Quality Assurance team members are highly experienced in GMP API manufacturing. The Quality Assurance Department, fully independent from the Production Department, oversees all elements of the GMP manufacturing process and Quality System, including:
- Procurement, quarantine, and release of materials
- Production (synthesis, purification, dilution, etc.)
- Quality Control
- Chain of custody
- Temperature tracking
- Labeling and documentation
For all aspects of GMP manufacture, the Quality Assurance team designs and implements standard operating procedures (SOPs) that are compliant with U.S. Food and Drug Administration guidance ICH Q7 Section 19. SOPs are regularly reviewed and updated to ensure compliance. Moravek’s Quality Assurance Department ensures that Moravek staff are trained in the appropriate SOPs and provides training as needed.
Moravek’s Director of Quality Assurance supervises the release of final GMP products and manages the generation and review of all documentation, such as master batch records, release specifications, and Certificates of Analysis. Because of Moravek’s experienced Quality Assurance team, you can be confident that your GMP 14C-labeled API will meet the previously agreed-upon release specifications and all essential regulatory requirements.