Industry and regulators seek global system that reduces regional differences. Sep 01, 2019 By Jill Wechsler BioPharm International Volume 32, Issue 9, pg 8–10 Regulatory officials in the United States, Europe, and other regions are collaborating with manufacturers to advance a new framework for managing chemistry, manufacturing, and controls (CMC) changes more efficiently across the product lifecycle. The process is outlined in the Q12 guideline developed by an expert working group formed under the International Council for Harmonization (ICH) (1). ICH is expected to approve a revised core Q12 guideline at the November 2019 ICH meeting in Singapore, along with more detailed annexes and a global training plan for industry and regulators. Click Here For Complete Article Text
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