ICH Q1A(R2), section II, B, 8, Stability Commitment (2.2.8) addresses this
question. Section 2.1.8 provides information regarding stability commitment
for drug substances.
Also, ANDAs and DMFs should include a commitment to place one batch of
drug product and drug substance, respectively, into the annual long-term
stability program, and to provide stability data in the annual reports.
