The company should document the rationale for the designated API starting material. Where in a
given process the designated regulatory API starting material comes will vary with each process.
One of the difficulties was trying to cover all possible situations, because that’s nearly impossible.
The decision to designate an API starting material is based on more than chemical logic. It is a
pharmaceutical consideration as well. Remember, there is a patient at the very end of every API
process who is suffering from a disease, and the goal to provide something to get rid of his illness
in a safe and reliable manner.
When you’re developing a new chemical process or API process you should be discussing your
choice of API starting material with the review division. At some point, you should come in and
talk to the reviewers and say, ‘this is what I consider to be my API starting material, this is where I
consider my API process begins. The reviewers are either going to agree with you or disagree,
and they might think that it’s further back in the process. But, this is something that you should
agree on early with the FDA review divisions, because it’s absolutely critical that you have
agreement with the Agency as to what you define as your API starting material and where your
API process begins.
