For biotechnological/biological products, a material produced during a manufacturing process that is not the drug substance or the drug product but for which manufacture is critical to the successful production of the drug substance or the drug product. Generally, an intermediate will be quantifiable and specifications will be established to determine the successful completion of the manufacturing step before continuation of the manufacturing process. This includes material that may undergo further molecular modification or be held for an extended period before further processing.
Partly processed material that must undergo further manufacturing steps before it becomes a bulk product
A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API. Intermediates may or may not be isolated. (Note: this guidance only addresses those intermediates produced after the point that a company has defined as the point at which the production of the API begins.)
