The International Council for Harmonisation (ICH) earlier this week announced the advancement of two guidelines to Step 4, or the implementation period of its process, and one question and answer document on the development and manufacture of drug substances to Step 2b of its process, meaning it enters a consultation phase.
ICH E6(R1): Guideline for Good Clinical Practice (GCP) advanced
CH Q3C(R6) Guideline advanced and it revises the permissible daily exposure (PDE) for methyl isobutyl ketone (MIBK), and adds triethylamine (TEA) as a new solvent.
ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)
For the full story read it here at http://www.raps.org/Regulatory-Focus/News
Source: Regulatory Affairs Professionals Society
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