What microbial controls is the manufacturer required to have in place for an API used in clinical trials for parenteral drug product even if the manufacturer has no responsibility for the end use of the API?

The same controls that any private company would be expected to have in place since it is an
API. In today’s global market, it would be hard to conceive that an API manufacturer would not
know the intended use of the API provided to a customer. Particularly, in the clinical trial arena
the API manufacturer knows what company is going to receive that API. In many cases, this is
the same corporation, because of your new drug substances, new APIs, both the API and the
final product are developed by innovative companies. The responsibility to ensure the API is
appropriately controlled for use in a parenteral would lie with the Drug Product manufacturer.