PhRMA, Drugmakers Find Duplicative Requirements in CMC Biologics Guidance

The FDA should avoid duplicating existing requirements in its updated guidance on chemistry, manufacturing and controls information for biologics, according to PhRMA and several drugmakers in comments to the agency.

In its comment on the proposed update to the 1997 CMC guidance, PhRMA urged the agency to avoid redundancy by removing requirements that manufacturers include validation protocols and data, a reference list of relevant SOPs, and a cross-reference to validation protocols or SOPs in CMC supplements and annual reports.

Sanofi also called for removing the requirement for a reference list of SOPs from the requirements for CMC supplements, noting that SOPs are already reviewed as part of GMP inspections.