Quality Assurance Release of [14C] under GMP

Moravek offers properly designed and implemented quality assurance systems, including GMP Standard Operating Procedures, to ensure that your GMP [14C] API obtains approval for use in clinical trials.

Moravek’s GMP Quality Assurance Team has over 30 years of experience in GMP API manufacturing, so you can have utmost confidence in our GMP quality control solutions. Our GMP Quality Assurance Team works closely with a variety of regulatory establishments and dozens of clients to design and implement complete, GMP-compliant systems and operating procedures. These solutions consistently satisfy all necessary compliance activities including procurement, quarantine and release of reagents, manufacturing, isolation, quality control, chain of custody, temperature tracking, proper labeling, documentation, and release of GMP [14C] API, all while adhering to FDA GMP guidance ICH Q7 Section XIX.

Since the addition of GMP ISO 7 Cleanrooms 2 and 3 in 2012, our GMP quality control solutions have successfully passed all client and regulatory body quality assurance inspections including a GMP inspection carried out by Merck and the California Department of Public Health. Moravek has passed all Quality Systems inspections and is approved to manufacture GMP [14C] API for clinical trials.