ComplianceOnline

FDA's Guidance on Development and Manufacture of Drug Substances

  • By: Staff Editor
  • Date: May 15, 2017
  • Source: www.fda.gov
Abstract:

FDA's Guidance on Development and Manufacture of Drug Substances

The US FDA, in November 2012, has announced its adoption of the ICH Q11 guideline on the development and manufacture of drug substances. The guidance explains both the traditional and enhanced approaches in developing and understanding the manufacturing process for a drug substance. It also offer details on the information that should be provided in Module 3 of the Common Technical Document (CTD) sections.

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