Newly Published FDA Guidance for Industry-cGMP Phase 1 Investigational Drugs: 

Is your business plan affected?

As you may have read in the recently published “Guidance for Industry – cGMP for Phase 1 Investigational Drugs”, the FDA now exempts phase 1 clinical investigational and exploratory products, from complying with 21CFR 211.  21CFR 211 regulations are directed for large scale commercial product manufacture, which may not be appropriate for clinical materials.  Scientifically sound cGMPs, emphasizing patient safety, still need to be applied when manufacturing phase 1 clinical trial products, complying with § 501(a)(2)(B) of the FD&C Act.  This new guidance provides approaches for complying with § 501(a)(2)(B) of the FD&C Act.

To summarize, this guidance document applies to all products, except those impacted by additional quality regulations. It also does not apply to compounds that are already in phase 2, or phase 3 clinical trials for other indications and marketed products used in phase 1 studies. The traditional responsibilities of the Quality Assurance (QA) role have been delegated to Quality Control (QC). This is somewhat in alignment with regulatory requirements for Dietary Supplements. All additional expectations for documented procedures, equipment and manufacturing environment, control and accurate record keeping remain basically unchanged.

At Safis Solutions we strive to provide our clients with a risk based compliance strategy that fits their phase of product development. The phase 1 quality system provided by Safis Solutions is directly in line with these recently published FDA expectations. Safis accomplished this through years of experience in dealing with and truly understanding the FDA’s expectations.

Please don’t hesitate to contact Safis Solutions directly with specific questions about how this new guidance may impact your business plan.