Quality Assurance Release of [14C] under cGMP

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

Moravek’s cGMP Quality Assurance Team has over 30 years of experience in cGMP API manufacturing, so you can have utmost confidence in our cGMP quality control solutions. Our cGMP Quality Assurance Team works closely with a variety of regulatory establishments and dozens of clients to design and implement complete, cGMP-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 cGMP [14C] API, all while adhering to FDA cGMP guidance ICH Q7 Section XIX.

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