When and where do we start applying CGMPs? For example, we may use isopropanol to make the reaction of our API or to purify API. We do not manufacture isopropanol, so does the manufacturer of isopropanol have to follow all the CGMPs that apply to us? Does the manufacturer of any excipient have to follow the CGMPs as we do?

This is one of those examples where using this material, isopropanol, based on its intended use,
could be classified as a solvent or an active pharmaceutical ingredient. If the company only uses
isopropanol in reactions to purify the API, then clearly, the isopropanol would be categorized as a
solvent or a raw material. However, if you are a drug manufacturer and you are receiving
isopropanol, and you’re producing rubbing alcohol, which is classified as a drug, then under that
scenario the isopropanol would be the active pharmaceutical ingredient. That’s why we have “the
intended use” clause in the Q7A definition because certain materials, depending on their intended
use, could or could not be classified as API.