FDA Clarifies ICH Guideline on Selecting and Justifying Drug Manufacturing Starting Materials

More than four years after adopting an ICH guideline on manufacturing processes, the FDA has responded to industry questions on justifying starting materials for chemical entity drug substances.

The draft question and answer guidance covers the implementation of a single section of the Q11 manufacturing guideline — first developed by the International Council for Harmonisation and adopted by the FDA in 2012 — and makes recommendations for the information that should be included in marketing applications.

The guidance makes it clear that the term “starting material,” as described in the Q11 guideline, is the same as the “API starting material” referenced in the ICH’s separate Q7 guideline covering good manufacturing processes.