Making sense of the FDA’s GMP and Regulatory Expectations for Early IND Products

The FDA’s recent guidance documents covering GMP requirements for Phase I products have considerably reduced some of the complexities early phase products face. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I. Although these new guidelines appear to remove the need to follow GMPs for […]

API Process Inspection –what does the FDA expect?

    API Process Inspection –what does the FDA expect? Ironical as it may sound; there is no API-specific GMP guideline from the FDA! It has only some broad, yet clearly laid out rules and expectations, which have to be adhered to. The FDA and API Process Inspection Rules regarding what the FDA expects are […]