Trade Group Asks for Changes to FDA Guidance on ICH Q12 in Public Comment

By PacConAdmin | November 1, 2021

The International Society for Pharmaceutical Engineering (ISPE) has proposed changes to the FDA’s draft guidance on postapproval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization (ICH) for makers of drugs and drug-device combination products.
Source: Drug GMP Report

Posted in Drug GMP Report