Quality Assurance Release of [14C] under GMP

Properly designed and implemented Quality Systems, including GMP Standard Operating Procedures, are essential to ensuring that your GMP [14C] API will succeed in receiving approval from regulatory bodies for use in a clinical trial.

The GMP Quality Assurance team at Moravek has over thirty years of industry experience in GMP API Manufacturing.

Moravek’s Quality Assurance team has worked closely with regulatory bodies and dozens of clients to design and implement comprehensive GMP compliant quality systems and operating procedures that consistently satisfy all essential 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 while adhering to FDA GMP guidance ICH Q7A.

Since the addition of GMP ISO 7 Cleanrooms 2 and 3 in 2012, GMP Quality Systems and facilities at Moravek 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 was approved to manufacture GMP [14C] API for clinical trials.

Moravek has manufactured over one hundred GMP [14C] APIs since 2012, all of which have met both our client’s Quality Assurance criteria as well as the acceptance criteria of the clinical trial regulatory bodies.

Moravek welcomes your Quality Assurance onsite inspection of our GMP facilities and systems. Please contact us to schedule an inspection.