- Review the article entitled “PREPARATION AND REVIEW OF CHEMISTRY, MANUFACTURING AND
CONTROL (CMC) SECTIONS OF CTD DOSSIER FOR MARKETING AUTHORIZATION”.
a. Using the ICH Q11 requirements as a framework, describe what sections and associated content are
needed to build a comprehensive Module 3 specifically for drug substance.
b. Where do you see gaps in the detail described in ICHQ11 versus the commonly cited queries during
application review by the regulatory agencies? Explain. - Based on the case study (pre-read #3) which used previously for the modules on ICHQ8 (R2), explain how
you would approach developing the respective drug substance sections for Generic Acetriptan Tablets, 20 mg.
Welcome to Legit Writing
