cGMP for Phase 1 Investigational Drugs

Back in July of this year the FDA issued a new direct final rule and associated guidance document that exempts most Phase 1 investigational drugs from complying with cGMP's. It is worth reviewing these documents to gain insight into the guidance that a company is not necessarily required to comply with all sections of 21 CFR parts 210 and 211 for products manufactured for a Phase 1 clinical trial. 

The FDA still retains oversight of all drugs used in Phase 1 trials and will continue to review the CMC section of each IND application to ensure that product safety and quality requirements are met.

This new rule will not likely change how large drug manufacturers approach how they produce products for Phase 1 trials since they likely already have the facilities and quality procedures in place for full GMP compliance. For small start-up organizations this new change may help streamline the drug development process.

For more on this topic see this piece written by Laura Bush the editor of BioPharm International magazine.