Comment from International Pharmaceutical Excipients Council of the Americas
AnonymousSupportAdvocacy
Summary: The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) supports the FDA's initiative to modernize the SUPAC guidances. They argue that the updates should align with modern regulatory science, such as Quality by Design (QbD) and ICH Q12, while moving away from rigid numerical thresholds toward science-based, risk-based control strategies.
IPEC-Americas Comments are attached.